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Supplementation of vitamin B12 or folic acid on hemoglobin concentration in children 6-36 months of age: A randomized placebo controlled trial.

Clinical nutrition (Edinburgh, Scotland)
August 1, 2017
Tivendra Kumar et al. (7 authors)
Comparative StudyJournal ArticleMulticenter StudyRandomized Controlled TrialHuman StudyClinical
Study Details

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

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
Anemia, Iron-DeficiencyBiomarkersChild, PreschoolDietary SupplementsDouble-Blind MethodFemaleFolic AcidFollow-Up StudiesHemoglobinsHomocysteineHumansIndiaInfantInfant Nutritional Physiological PhenomenaIron, DietaryMalePrevalenceReceptors, TransferrinRiskSolubilityUrban HealthVitamin B 12
Study Links
Quality Scores
SafetyNot Assessed
Efficacy20/10
Quality85/10
Citation Metrics
Total Citations8
Citations/Year1.0
Relative Citation Ratio0.51
NIH Percentile27.6%
Research Impact Scores
APT Score0.50
Weight Score1.93
Normalized Score0.45
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