Supplementation of vitamin B12 or folic acid on hemoglobin concentration in children 6-36 months of age: A randomized placebo controlled trial.
Study Goal
The researchers aimed to determine whether folate or vitamin B12 supplementation, alongside iron, improves hemoglobin concentration in young North Indian children with anemia.
Results Summary
Iron supplementation for the initial 2 months had limited effect on anemia, as nearly 90% of children remained anemic after 6 months. Supplementation with folic acid and/or vitamin B12 did not improve hemoglobin concentration.
Population
Young children from low-to-middle income neighborhoods in New Delhi, India, with baseline anemia.
Effective Dosage
Not specified for iron (only mentioned as "daily for 2 months").
Duration
Iron supplementation for 2 months; overall study duration was 6 months.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
folate or vitamin B12 given daily for 6 months | no change | hemoglobin (Hb) concentration | young North Indian Children | - | does not improve | #1 |
2 RDAs of vitamin B12 | no change | Hb concentration | children | - | did not improve | #2 |
folic acid | no change | Hb concentration | children | - | did not improve | #3 |
both | no change | Hb concentration | children | - | did not improve | #4 |
placebo | decrease | Mean Hb concentration | children | - | decreased | #5 |
iron supplementation daily for 2 months | no change | anemia at 6 mo | children with anemia at baseline | - | had limited effect on | #6 |
folic acid and/or vitamin B12 for 6 months | no change | Hb concentration | young children | - | does not improve | #7 |
BACKGROUND & AIMS: The main objective of this report is to measure to what extent folate or vitamin B12 given daily for 6 months to young North Indian Children improves hemoglobin (Hb) concentration. METHODS: In a randomized placebo controlled trial in low-to-middle income neighborhoods in New Delhi, India, children were randomized into four groups in a 1:1:1:1 ratio and supplemented daily for 6 months with 2 RDAs of vitamin B12, folic acid, both, or placebo. All children with anemia at baseline were given iron supplementation daily for 2 months. We measured the plasma concentrations of soluble transferrin receptor (sTfR), folate, vitamin B12, total homocysteine (tHcy) and Hb in 262 children. RESULTS: Mean Hb concentration decreased in all four study groups during the six months of follow up and supplementation of either or both of the vitamins did not improve the Hb concentration. Iron supplements for the initial 2 mo had limited effect on anemia at 6 mo as almost 90% were still anemic at study end. CONCLUSION: Supplementation of folic acid and/or vitamin B12 for 6 months does not improve Hb concentration in young children. Our findings do not argue for widespread vitamin B12 or folic acid supplementation to combat anemia. Our results also call for alternative strategies to improve iron status and treat iron deficiency anemia. CLINICAL TRIAL REGISTRY: NCT00717730 at www.clinicaltrials.gov, CTRI No.: CTRI/2010/091/001090 at www.ctri.nic.in.