| Methods | Trial conducted in New Dehli and Tamil Nadu, India. | |
| Participants | Pregnant women with gestational age 22 ± 2 were eligible to participate in the trial. A total of 647 pregnant women participated in the trial. Women with chronic diseases like heart diseases, tuberculosis, leprosy, chronic diarrhoea and a Hb < 5 g/100 mL were excluded from the study. | |
| Interventions | There were total of 7 study groups. 2 in the control group and 5 in the intervention group. 1 of the control groups received placebo and other received vitamin B12 and folic acid alone. 4 intervention groups received vitamin B12, folic acid and iron in a range of 30 to 240 mg. The fifth intervention group received 120 mg of iron without vitamin B12 and folate. Supplementation was given for 10‐12 weeks. | |
| Outcomes | Outcomes were improvement in maternal Hb/haematocrit, iron absorption from maternal gut, fetal birthweight, maternal and fetal Hb 3 months postpartum, hookworm infestation in mother and side‐effects of supplementation. | |
| Notes | None of the outcomes were reported in a format that allowed inclusion of the data in this review. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "By reference to previously prepared random tables the women were allocated to one of the two streams A or B" and "within each stratum subjects were allotted to final treatment groups according to a set of random numbers". Comment: probably done. |
| Allocation concealment (selection bias) | High risk | Quote: "By reference to previously prepared random tables the women were allocated to one of the two streams A or B" and "within each stratum subjects were allotted to final treatment groups according to a, set of random numbers". Comment: probably not done. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition was 30% and reasons for it were reported. |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes mentioned in the methods section were presented in the paper. |
| Other bias | Low risk | Comment: no other bias was identified. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All the tablets had the same appearance and had the daily folic acid and iron dose divided into two tablets". Comment: participants, caregivers probably blinded to the treatment assignment. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All the tablets had the same appearance and had the daily folic acid and iron dose divided into two tablets". Comment: outcome assessors probably blinded to the treatment assignment. |