TABLE I Randomized Control Studies Comparing the Clinical Efficacy of Various Iron Salts.
Author/ Year/ Country |
Salt | Age |
Sample size |
Study design |
Outcome parameters |
Results |
Ashmead, et al. 2001 Latin America(11) |
Ferrous bisglycinate |
6 to 36 mo. |
40 |
RCT: Two groups: FeSO4 vs. FBG @ 5 mg/kg for 28 days |
Hemoglobin and Ferritin |
Both groups had significant hemoglobin (p < 0.001); group treated with FBG had significant (p < 0.005) in plasma ferritin. Iron bioavailabilities were 26.7% for FeSO4 and 90.9% for FBG. |
Szarfarc, et al. 2001 Brazil(33) |
Ferrous bisglycinate (FBG) |
Pregnant Women |
145 (n=71 vs. n=74) |
RCT: Two groups: FeSO4 40 mg/d vs. FBG 15 mg/day for a min. of 13 weeks |
Hemoglobin, transferrin saturation and serum ferritin |
Iron depletion was found in 30.8% of the women treated with ferrous bisglycinate and in 54.5% of the women that consumed ferrous sulfate. Higher non-compliance rates were seen with ferrous sulphate. |
Aronstam,et al 1982 UK(12) |
Ferrous Glycine sulphate |
adults |
40 |
RCT-crossover: Ferrous fumarate or FGS for 4 weeks after which they were switched to the other drug |
Hemoglobin, PCV and MCV |
Significant in Hb, PCV and MCV were similar. In 3 patients, side effects were severe with ferrous fumarate with interruption of treatment in 2 and withdrawal from the study in the other. FGS group had no withdrawal of treatment. |
Sozmen, et al. 2003 Turkey(18) |
Iron Polymaltose complex (IPC) |
8-168 mo. |
25 (n=14 vs n=11) |
RCT: Two groups: FeSO4 vs. IPC @ 6 mg/kg for 3 mo. f/b 3 mg/kg for 3 mo. |
Hemoglobin, Serum Iron, Plasma Cu, ceruloplasmin & Zinc |
Hematological parameters showed equivalent rise in the two groups. Copper and ceruloplasmin metabolisms were affected by ferrous iron supplementation. |
Jacobs, et al. 1993 South Africa(34) |
Iron Polymaltose complex (IPC) |
Healthy blood donors |
159 (Gp1:51; Gp2: 53; Gp3: 55) |
RCT: Three groups: FeSO4 @ 60 mg OD vs. IPC @100 mg OD vs. IPC @ 100mg BD |
Hemoglobin, %age transferrin saturation, serum ferritin |
80% of patients in Groups 1 & 3 reached normal Hb levels by 12 weeks, compared to 50% in Gp. 2. Similarly, the proportion of patients improving their transferrin saturation to normal was significantly better in Groups 1 & 3 than in Gp. 2 (P < 0.01). However serum ferritin level, was better in Group 1 (p < 0.01); there was no difference in this respect between Groups 2 & 3 |
Devasthali,. et al. 1991 India(26) |
Carbonyl iron |
Healthy blood donors |
49 |
RCT: Two groups FeSO4 vs Carbonyl iron |
Hb,MCV, Retic. count, platelet count, se iron, TIBC, transferrin saturation or FEP |
Mean values for hemoglobin concentration, mean corpuscular volume, corrected reticulocyte count, platelet count, serum iron, total iron-binding capacity, transferrin saturation or erythrocyte protoporphyrin did not differ significantly between the two groups throughout the study. After 16 weeks of therapy, the mean increase in hemoglobin iron was similar in both groups (p = 0.2). Estimates of net changes in total body iron suggested that the overall bioavailability of carbonyl iron was high, about 70% that of ferrous sulfate. |
Gordeuk VR, et al. 1990 Ohio, USA(25) |
Carbonyl iron |
18-40 years- Women |
99 |
RCT: Two groups: 100 mg carbonyl iron vs. placebo for 56 days |
Hb, net iron absorption, rates of deferral from repeat donation |
At Day 56, estimated net iron absorption from therapy or diet, or both, was sufficient to replace iron in 85 percent of those receiving carbonyl iron but in only 29 percent of those taking placebo (p less than 0.001). The rates of deferral from repeat donation were 8 percent in the carbonyl iron group and 36 percent in the placebo group (p < 0.01). |
Gordeuk VR, et al. 1987 Ohio, USA(29) |
Carbonyl iron |
Menstrua- ting women |
75 |
RCT: 3 groups: 1) carbonyl iron 600 mg; 2) FeSO4, 300 mg (60 mg Fe++); or 3) placebo, each given TDS *1wk |
Hb, MCV, FEP, Se ferritin, Se iron, TIBC, and %age sat. of TIBC |
The prevalence of gastrointestinal side effects was similar in both groups taking iron. At the end of the study there was no laboratory evidence of change in iron status in women who received carbonyl iron (n = 15). In those treated with ferrous sulfate (n = 17) the mean TIBC increased (p < 0.001), and in the placebo group (n = 19) there were decreases in mean MCV (p less than 0.01), serum ferritin (p <0.001), and per cent saturation (p = 0.027) with an increase in mean TIBC (p = 0.004). |
Note: Only RCTs involving comparison with placebo group or other iron salts are included in this Table.