|
Indian Pediatr 2017;54: 567-573 |
|
Prevention and Treatment of Vitamin D and
Calcium Deficiency in Children and Adolescents: Indian Academy
of Pediatrics (IAP) Guidelines
|
Anuradha Khadilkar, Vaman Khadilkar, Jagdish
Chinnappa, Narendra Rathi, Rajesh Khadgawat,
S Balasubramanian, Bakul Parekh and Pramod Jog
From Indian Academy of Pediatrics ‘Guideline for
Vitamin D and Calcium in Children’ Committee.
Correspondence to: Dr. Anuradha Khadilkar, Deputy
Director and Consultant Pediatrician, Hirabai Cowasji Jehangir Medical
Research Institute, Jehangir Hospital, Pune, India.
[email protected]
Received: November 26, 2016;
Initial review: January 10, 2017;
Accepted: May 20, 2017.
|
Justification: Vitamin D deficiency (VDD) is being increasingly
reported from India from all age-groups. Reports suggest that VDD
affects all age groups, from neonates to adolescents. Further,
habitually low calcium intakes are also reported in Indian children.
Given the multiple guidelines, peculiarities of Indian circumstances,
changing lifestyles, and lack of fortification, the Indian Academy of
Pediatrics (IAP) felt the need for a Practice Guideline for
Pediatricians for the prevention and treatment of vitamin D and calcium
deficiency in children and adolescents.
Process: The ‘Guideline for
Vitamin D and Calcium in Children’ committee was formed by the IAP in
September 2016. A consultative committee meeting was held in November
2016 in Mumbai. Evidence from Indian and international studies and other
previous published recommendations, which were pertinent to the Indian
circumstances, were collated for the preparation of these guidelines.
Objectives: To present a practice
guideline for pediatricians for the prevention and treatment of
deficiency of vitamin D and calcium in the Indian context.
Recommendations: For the
prevention of rickets in premature infants, 400 IU of vitamin D and
150-220 mg/kg of calcium, and in neonates, 400 IU of vitamin D and 200
mg of calcium are recommended daily. For prevention of rickets and
hypocalcemia in infants (after neonatal period) upto 1 year of age, and
from 1-18 years, 400 IU and 600 IU vitamin D/day and 250-500 mg/day and
600-800 mg/day of calcium, respectively, are recommended. For treatment
of rickets in premature neonates, infants upto 1 year and from 1-18
years, 1000 IU, 2000 IU and 3000-6000 IU of vitamin D daily,
respectively, and elemental calcium of 70-80 mg/kg/day in premature
neonates and 500-800 mg daily for all children over that age are
recommended. Larger doses of vitamin D may be given from 3 months to 18
years of age as 60,000 IU/week for 6 weeks.
Keywords: Consensus statement, Hypovitaminosis
D, Management, Rickets.
|
V itamin D deficiency is increasingly being
recognized the world over as also in India [1-5]. Reports from various
parts of India and in all age groups from neonates to adolescents as
well as pregnant and lactating mothers have reported vitamin D
deficiency to the tune of 30-90% [6-8]. Further, habitually low calcium
intakes are reported in children and adolescents from several studies
all over India, especially those from lower socio-economic classes
[9,10]. Given that vitamin D and calcium are both critical for
musculoskeletal health in growing years, addressing the issues of their
deficiency in the pediatric and adolescent population is critical.
Deficiency of vitamin D (with or without calcium
deficiency) may result in rickets in an infant or adolescent or
osteomalacia (abnormal mineralization of bone matrix) and muscle
weakness in an older child/adolescent [11]. Vitamin D deficiency may
also have a negative impact on the peak bone mass resulting in low bone
mineral density in childhood, which may subsequently result in
osteoporosis in adulthood [12]. Rickets in a neonate resulting from
maternal vitamin D deficiency may result in hypocalcemic seizures and
rarely cardiomyopathy [13]. There is lack of consensus amongst
clinicians and scientists on the role of vitamin D supplementation in
relation to extraskeletalal effects particularly in pediatrics; this
Guideline therefore, does not deal with these effects of vitamin D [14].
Rickets resulting from deficiency of vitamin D and/or calcium deficiency
may be prevented and treated with adequate intake of vitamin D and
calcium [15]. However, children with vitamin D deficiency, without
raised Parathormone (PTH) or signs of rickets are not at an increased
risk of fractures [16].
Less than 10% of vitamin D is derived from the diet
while close to 90% is synthesized in the skin with sunlight exposure
[17]. Socio-cultural practices, darker pigmentation, a diet low in
calcium and high in phytates and oxalates which depletes vitamin D,
absence of fortification with vitamin D, genetic factors such as
increased 25(OH)D-24-hydroxylase, which degrades 25(OH)D to inactive
metabolites, geographical location of various places in the country
(India extends from 8 to 38 degrees north latitude) and environmental
pollution are some reasons proposed for vitamin D deficiency in Indian
children [18-21]. Together with these factors, changing lifestyles with
sedentary behavior in children with indoor lifestyle (avoiding optimal
hours of sun exposure between 10 AM to 3 PM, the best time to form
Vitamin D in the skin) further reduce the sunlight exposure and thus
increase the tendency for vitamin D deficiency [21-23]. Further, very
few Indian foods are fortified with vitamin D, and that too, with small
amounts [23]. Premature babies and children with renal, hepatic
disorders, malabsorptive states, etc. are at special risk for
metabolic bone disease [24] .
Given the plethora of literature on vitamin D
deficiency, multiple guidelines suggested by various international
bodies, lack of consensus about the ranges for deficiency and
sufficiency, peculiarities of the Indian circumstances, evidence from
India suggesting high prevalence of vitamin D and calcium deficiency in
the pediatric population [16,24-26], the practitioner may be confused
regarding appropriate prevention and treatment of vitamin D and calcium
deficiency. The Indian Academy of Pediatrics (IAP) therefore felt the
need for a practice guideline for pediatricians for the prevention and
treatment of vitamin D and calcium deficiency in children and
adolescents. These guidelines do not include conditions causing
non-nutritional rickets; e.g., renal disorders, disorders of the
parathyroid hormone axis.
Methods
The ‘Guideline for Vitamin D and Calcium in Children
Committee’ was formed by the IAP in September 2016. The consultative
committee scrutinized the methodology, results and scientific content of
the manuscript in November 2016 in Mumbai after data from an extensive
search on prevalence of deficiency of vitamin D and calcium from India
was performed. Guidelines on the deficiency of vitamin D and calcium
with reference to deficiencies for children and adolescents published by
various bodies in Indexed journals were identified through
internet-based search engines viz. Google, PubMed and Embase
[16,24-27]. Indian studies reporting the prevalence of vitamin D
deficiency and intakes of calcium were also reviewed. Evidence from
Indian studies and other previously published recommendations, which
were pertinent to the Indian circumstances, were collated for
preparation of these guidelines. For vitamin D, the guidelines are based
on the assumption of minimal sun exposure [26].
Definitions
This is based on the serum concentrations of 25(OH)D.
Although professional bodies recommend that the assessment should be
performed by tandem mass spectrometry (TMS), most reports from India
suggest that these are performed by enzyme-linked immunosorbent assay,
chemiluminescence or radio-immuno assay. Very few centers have the
facility for assessment of vitamin D with TMS. Although a fasting
specimen is recommended, it is not required; further, diurnal variations
are also not a major consideration [28,29]. Given the various methods
and the variability in the values of vitamin D using different assays,
reports for serum 25(OH)D should be interpreted with care, taking into
account the laboratory and type of assay employed. Measurement of the
active form of vitamin D, 1,25-dihydroxycholecalciferol for the
assessment of vitamin D deficiency is not recommended [25]. Data suggest
that 20 ng/mL (50 nmol/L) can be set as the serum 25(OH)D level that
coincides with the level that would cover the needs of 97.5 percent of
the population [16,26]; thus, vitamin D concentrations of >20 ng/mL (50
nmol/L) are considered as sufficient, between 12-20 ng/mL (30-50 nmol/L)
as insufficient and <12 ng/mL (<30 nmol/L) as deficient [16].
Calcium deficiency is difficult to define as there is
no specific biochemical marker for the reserves of calcium (like 25(OH)D
for vitamin D); therefore, these guidelines refer to dietary calcium
deficiency [30].
Although ensuring adequacy is important, there is
also concern about excessive intake and administration of vitamin D,
particularly on the basis of only low 25(OH)D concentrations. Toxicity
is defined as vitamin D concentrations of 25(OH)D of >100 ng/mL (250
nmol/L) with hypercalcemia, hypercalciuria and suppressed PTH
concentrations [31]. Following inadvertent high doses of vitamin D,
testing for serum levels of calcium and vitamin D are recommended,
especially in children with symptoms of hypercalcemia such as
irritability, constipation and polyuria [32].
Hypercalcemia (that can result in vascular and soft
tissue calcification, nephrocalcinosis, nephrolithiasis, etc.)
occurs when serum calcium concentrations are above 10.5 mg/dL (reference
to the laboratory values is also recommended) [33]. Preferably, serum
ionized calcium may be assessed as 1 gm% reduction in serum albumin will
reduce total serum calcium by 0.8 mg% [34].
Tolerable upper limit (i.e. the maximum level
of total chronic daily intake of a nutrient from all sources judged to
be unlikely to pose a risk of adverse health effects to humans) for
intake of vitamin D and calcium during neonatal period, 1-12 months,
1-18 years are 1000 IU/day, 1000-1500 IU/day, 3000-4000 IU/day and 1000
mg/day, 1000-1500 mg/day, and 2500-3000 mg/day, respectively (Table
1) [16,25,33,35]. Larger doses may be required for treatment of
rickets; however, tolerable upper limits are not to be exceeded without
supervision.
TABLE I Recommendations for Vitamin D and Calcium Deficiency – Prevention and Treatment
|
Vitamin D |
Calcium |
|
Prevention |
*Tolerable |
Treatment |
Treatment |
Prevention
|
*Tolerable |
Treatment
|
Age |
|
upper limit |
|
with large |
|
upper limit
|
|
|
|
|
|
dose (oral
|
|
|
|
|
|
|
|
route preferred) |
|
|
|
Premature |
400 |
1000 |
1000 |
NA |
Intake of 150
|
1000
|
Maximum
|
neonates |
IU/day |
IU/day |
IU/day |
|
to 220 mg/kg
|
mg/day |
of 175–200 |
|
|
|
|
|
per day |
|
mg/kg/day |
Neonates |
400 IU/day |
1000 IU/day |
2000 IU/day$ |
NA
|
200 mg/day |
1000 mg/day |
500 mg/day |
1-12 months |
400 IU/day |
1000-1500
|
2000 IU/day$ |
60000 IU
|
250-500 |
1000-1500
|
500 mg/day |
|
|
IU/day |
|
wkly for |
mg/day |
mg/day
|
|
|
|
|
|
6 weeks (over
|
|
|
|
|
|
|
|
3 mo of age) |
|
|
|
1-18 years |
600 IU/day |
3000 IU day till
|
3000/-6000 |
60000 IU wkly |
600-800 |
2500 mg/day
|
600-800
|
|
|
9 years, 4000 |
IU/day$ |
for 6 weeks |
mg/day |
till 8 years and |
mg/day
|
|
|
IU/day from 9-18
|
|
|
3000 mg/day for |
|
|
|
|
years
|
|
|
|
9-18 years |
|
At-risk groups
|
400-1000 |
as per age |
as per age |
as per age
|
as per age |
as per age |
as per age
|
|
IU/day |
group |
group |
group |
group |
group |
group |
$For a minimum of 3 months; after
treatment, daily maintenance doses need to be given; *Tolerable
Upper Limit - the maximum level of total chronic daily intake of
a nutrient (from all sources) judged to be unlikely to pose a
risk of adverse health effects to humans. |
Screening for vitamin D deficiency:
Routine screening of healthy children for vitamin D deficiency is not
recommended [16,25]. However, screening may be performed for children,
who are at risk of vitamin D deficiency, for determination of vitamin D
concentrations and treatment [25]. Monitoring 25(OH)D levels in the
population is not practical because of the need for drawing blood, high
monetary cost of assessment, and also a low positive predictive value;
and is thus reserved for high-risk groups.
Route of administration: Oral treatment is
recommended; reports suggest that oral administration of vitamin D
restores vitamin D concentrations more rapidly than by the intramuscular
(IM) route [16]. This is especially important in the Indian context as
injectable preparations of vitamin D are inadvertently used in very
large doses for longer periods. The IM route with larger doses may only
be considered when compliance or absorption from the gut is an issue.
Further, vitamin D may be administered with a meal or on an empty
stomach as absorption is independent of fed state [25].
Recommendations
The recommendations for prevention and treatment of
vitamin D and calcium deficiency for various age groups and for at-risk
groups are provided in Table I. Assessment of dietary
intake of calcium to ensure that children are having adequate calcium
for optimum bone health is required.
Prevention of Deficiency of Vitamin D and Deficiency
of Calcium
Premature neonates: Calcium and phosphorus
in breast milk do not meet the needs of rapidly growing premature
infants who have missed some of the critical period of intrauterine bone
growth; this puts them at a higher risk for metabolic bone disease [36].
Exposure to medications that alter mineral levels, immobilization, and
long-term parenteral nutrition may further increase the risk of the
premature baby for metabolic bone disease (MBD) [37,38]. Routine
measurement of serum 25(OH)D levels in premature infants is not
recommended; however, in the presence of a likely impairment of
25-hydroxylation, such as might be present in an infant with cholestasis,
measurement of serum 25(OH)D level may be considered [26]. Enteral
calcium intake of about 150 to 220 mg/kg per day, phosphorous intake of
75-140 mg/kg/day and vitamin D intake of 400 IU/day is recommended [37].
Backstrom, et al. have found that an intake of 200 IU/kg of
vitamin D in premature infants in first 6 weeks after birth lead to mean
25(OH)D concentrations of around 50 nmol/L [38]. It is however critical
to avoid excessive administration of vitamin D that can lead to
hypervitaminosis, especially as various preparations with varying amount
of vitamin D and calcium are available in India.
Neonates and infants upto 1 year of age:
Although there is likelihood of a high prevalence of vitamin D
deficiency in apparently healthy term neonates who are born to vitamin D
deficient mothers, due to financial and logistic limitations in the
Indian context, routine screening for vitamin D concentrations in this
age group cannot be recommended. Breastmilk is not an adequate source of
vitamin D [39]; 400 IU of vitamin D has been shown to maintain serum
25(OH)D concentrations at >50 nmol/L in breastfed infants [40]. Further,
for formula-fed infants, the amount of formula milk to obtain 400 IU/day
would be close to a liter, which a baby may not consume daily. Thus, for
all newborns, 400 IU of vitamin D supplementation is recommended till
one year of age; it is also recommended that supplementation be started
in the first few days of life. It is critical to give careful
instructions about the dosage and administration and to avoid excessive
administration of vitamin D, which could lead to hypervitaminosis,
particularly in infants.
There are no reports of full-term, vitamin D-replete
infants developing calcium deficiency when exclusively fed human milk
[41]. Also, calcium absorption is high in neonates to the tune of around
60% (facilitated by lactose from breast milk); hence, the adequate
intake for calcium based on amounts of calcium in breast milk is 200 mg.
In the first year of life, if dietary calcium intake is not adequate
(250-500 mg), calcium supplementation is justified [42,43].
Maternal concentrations of vitamin D determine the
status of vitamin D of her fetus and newborn [44]. Thus, the neonate of
a mother who has vitamin D deficiency is also likely to be vitamin D
deficient. Hence, it is recommended that pregnant mothers receive 600 IU
of vitamin D daily [25]. This supplementation is also to be continued
during lactation. Breastmilk contains very little vitamin D, which is
inadequate for the newborn who requires around 400 IU/day [39]. However,
to increase content of breast milk vitamin D, very large doses are
required to be given to lactating mothers. Thus, it is recommended that
infants be supplemented with 400 IU daily and mothers continue to take
600 IU daily for their own vitamin D needs. Maternal dietary intake of
calcium is not associated with breast milk content; however, it is
recommended that mothers take 1200 mg of calcium, as advised by the ICMR
[17].
Children older than 1 year and adolescents:
Vitamin D deficiency is likely to occur during rapid phases of
growth as well as when there are physiological changes; Indian children
are spending more and more time indoors and intake of milk and other
calcium-containing foods is also low. As a result of this, as per
reports, a very high percentage of children have vitamin D
concentrations below 50 nmol/L. Hence, it is recommended that all
children and adolescents be supplemented with 600 IU of vitamin D that
is believed to maximize bone health [2,25]. Along with the vitamin D, it
is recommended that adequate amounts of calcium i.e. 600-800
mg/day should also be supplemented/derived from dietary sources; this
may be obtained from 2-3 servings of milk and milk products/day (as per
recommendations from the Indian Council of Medical Research) [17].
At-risk groups: In cases where there is an
increased risk of deficiency of vitamin D such as in children with fat
malabsorption, liver disease or renal insufficiency, transplant
recipients, those on anti-seizure medications, children on treatment for
malignancy, restricted sun exposure such as in children with physical
disabilities, history of rickets, children with predisposition to
osteoporosis such as in hypogonadism or Cushing’s syndrome, etc.,
higher doses of vitamin D may be required to ensure adequate
concentrations of vitamin D [16,25,26]. Thus, for at-risk infants,
400-1000 IU/day and from 1 year onwards, 600-1000 IU/day may be required
to maintain 25(OH)D concentrations above 50 nmol/L [25]. Screening for
vitamin D concentrations may be performed in this group of children and
treatment with vitamin D advised accordingly. Repeat measurements of
vitamin D at 3-6 monthly intervals may be performed as clinically
indicated, especially if follow up radiological assessments show
poor/inadequate healing of rickets. Adequate calcium intake as per the
age group (Table 1) should also be ensured.
There is an inverse association of body fat with
vitamin D concentrations; vitamin D being a fat soluble vitamin, is
sequestrated in adipose tissue [45]. Thus, children who are obese may be
given at least two to three times (between 400-1000 IU/day) more vitamin
D for their age group to satisfy their body’s vitamin D requirements
[25].
Treatment of Deficiency of Vitamin D and Deficiency
of Calcium
For preterm infants with rickets/metabolic bone
disease who are able to tolerate oral/enteral feeding, calcium intake of
upto a maximum of to a maximum of 70-80 mg/kg/day of elemental calcium
and 40-50 mg/kg/day elemental phosphorus is indicated [37]. Preterm
infants with rickets are also provided the tolerable upper intake of
1000 IU/day of vitamin D (target serum 25(OH)D concentration of >20
ng/mL (50 nmol/L) [27].
For the emergency treatment of hypocalcemia resulting
in seizures in a neonate, calcium gluconate in a dose of 2 mL/kg as slow
intravenous infusion and calcitriol (1-25(OH) 2
D3) is
recommended in a dose of 20-50 ng/kg/day. Also, vitamin D in a dose of
1000 IU/day is recommended [46].
For neonates and infants till 1 year of age, daily
2000 IU of vitamin D with 500 mg of calcium for a 3-month period is
recommended. At the end of 3 months, response to treatment should be
reassessed and treatment continued, if required [16]. Response to
treatment may be assessed on clinical biochemical and radiological
parameters. If larger doses of vitamin D are to be given, then, 60,000
IU of vitamin D weekly for 6 weeks is recommended (only in infants older
than 3 months of age) [16]. After completion of this therapy with weekly
doses, maintenance doses of 400 IU of vitamin D daily and 250-500 mg of
calcium are necessary.
From one year onwards till 18 years of age, 3000-6000
IU/day of vitamin D along with calcium intake of 600-800 mg/day is
recommended for a minimum of 3 months. For larger doses (oral preferred)
60,000 IU of vitamin D weekly for 6 weeks may be administered [25]. The
maintenance doses of 600 IU/day of vitamin D and 600-800 mg of calcium
need to be continued post therapy. Complete healing at 12 weeks has been
observed in higher percentage of children with rickets who received
combined therapy with vitamin D and calcium [47]. Calcitriol, the active
form of vitamin D, should not be used for vitamin D deficiency rickets.
Minimum treatment for vitamin D and calcium deficiency is advised for 3
months. If there are no radiological and biochemical signs of healing
after 3 months, the patient may need to be investigated for
non-nutritional rickets [48].
Available Preparations
Vitamin D3 (cholecalciferol) has been reported to
have greater efficacy in raising 25(OH)D concentrations, most
supplements available thus contain D3. Reports suggest that there is
variability in cholecalciferol content of commercial preparations
available in the Indian pharmaceutical market; thus caution should be
used when prescribing preparations of vitamin D [49].
Most calcium supplements contain calcium carbonate,
though preparations with gluconate and citrate are also available.
Calcium carbonate contains the highest amount of elemental calcium (40%)
compared to other preparations (gluconate, citrate). Thus, given the
lower price and higher amount of elemental calcium, it should be the
first choice [50]. Supplements containing calcium citrate may be taken
with or without food. However, if the preparation contains calcium
carbonate or any other form of calcium, it should be taken with food.
All forms of calcium work better if taken in divided doses; however,
compliance also needs to be considered. Very few preparations containing
only calcium salts (without vitamin D) are available.
Conclusions
Considering the increased prevalence of vitamin D
deficiency and the confusion about supplementation and treatment of
vitamin D deficiency for various age groups, the IAP has put forth
recommendations for prevention and treatment of vitamin D and calcium
deficiency. The recommendations are in line with other international
organizations. As a long term policy, fortifying everyday staple foods,
which will be consumed by the at-risk segments of the population, with
calcium and vitamin D is the solution to the problem. Till the time this
can be implemented, supplementation of infants with 400 IU, and children
and adolescents with 600 IU daily and higher doses for at-risk groups,
with adequate calcium intake for prevention of deficiency is necessary.
Adequate intake of calcium and continuing maintenance doses of vitamin D
after treatment of rickets is warranted.
Disclaimer: The present guidelines are developed
for the assistance of pediatricians in accordance with current
scientific evidence and guidelines presented by major international
bodies for preserving and promoting musculoskeletal health in children;
however, many areas are still not clearly defined. Vitamin D has been
reported to have many other important health benefits and when rigorous
proof is available, guidelines will be suitably modified. These
guidelines cannot establish a standard of care, and decisions about
treatment should be based on the judgement of the pediatrician on a
case-to-case basis.
Contributors: AK, VK: helped in conceptualizing
and designing the guideline; AK,VK,JC,NR,RK,SB: contributed to the
review of literature and helped with the manuscript writing; AK: will
act as the corresponding author.
Funding: The cost of travel for the Consultative
meeting of the ‘Guideline for Vitamin D and Calcium in Children
Committee’ was borne by Cadila pharmaceutical Pvt. Ltd. India.
Competing interests: None stated.
Annexure
Committee Members for Guideline for
Vitamin D and Calcium in Children Committee
Chairperson: Pramod Jog,
President Indian Academy of Pediatrics, 2016; Co-Convener:
Anuradha Khadilkar and Vaman Khadilkar; Committee Participants:
Jagdish Chinnappa, Narendra Rathi, Rajesh Khadgawat, S Balasubramanian,
Bakul Parekh.
All members except BP participated in the meeting by
either being there personally or through a conference call. All members
satisfy the authorship criteria.
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