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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.
Kumar, T, Taneja, S, Sachdev, HPS, Refsum, H, Yajnik, CS, Bhandari, N, Strand, TA, ,
Clinical nutrition (Edinburgh, Scotland). 2017;(4):986-991
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.
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Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique.
Nwaru, BI, Salomé, G, Abacassamo, F, Augusto, O, Cliff, J, Sousa, C, Regushevskaya, E, Parkkali, S, Hemminki, E
Public health nutrition. 2015;(6):1127-34
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Abstract
OBJECTIVE Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique. DESIGN A pragmatic randomized controlled trial. SETTING Two health centres (1° de Maio and Machava) in Maputo, Mozambique. SUBJECTS Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 μg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid). RESULTS The level of adherence was 79% for having two or more visits, 53% for adequate prenatal care and 67% for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other. CONCLUSIONS The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.