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Interventions and public health nutrition

Impact of daily-supervised administration of a package of iron and folic acid and vitamin B12 on hemoglobin levels among adolescent girls (12–19 years): a cluster randomized control trial

European Journal of Clinical Nutrition volume 75, pages 1588–1597 (2021)Cite this article

Subjects

Abstract

Objective

The prevalence of anemia has remained high among Indian adolescent girls over the past decade, despite the ongoing iron and folic acid (IFA) supplementation program. This study was conducted to assess the impact of daily supplementation of a package of IFA with vitamin B12 on hemoglobin levels among adolescent girls.

Methods

A community-based cluster-randomized trial was conducted in the rural block of Faridabad District, Haryana, India in the year 2017. A total of 760 adolescent girls in the age group of 12–19 years with mild and moderate anemia were selected from government schools. Daily-supervised administration of iron and folic acid was conducted for 90 days: experimental group—IFA (iron (60 mg), folic acid (500) mcg), and cyanocobalamin (1000 mcg), control group—IFA and placebo. Hemoglobin, serum ferritin, and vitamin B12 levels were assessed at baseline and endline.

Results

Two-hundred adolescent girls completed 90 doses of daily supplementation. The mean hemoglobin (experimental group: 1.3 ± 1.0 g/dL, control group: 1.6 ± 1.2 g/dL, P = 0.004) and ferritin levels (experimental group: 18.6 ± 31.5 ng/mL, control group: 18.8 ± 35.0 ng/mL, P = 0.188) increased in both the control and experiment groups. Serum vitamin B12 deficiency significantly reduced to 2.5% in the experimental group and ferritin deficiency alleviated in more than 96% of the girls post intervention.

Conclusions

Daily supplementation of IFA with/without vitamin B12 for 90 days eliminated iron, vitamin B12 deficiency and reduced the overall proportion of anemia by 53.5%. However, addition of vitamin B12 to IFA supplementation had no impact on improving the hemoglobin levels among adolescent girls. The present study does not recommend provision of vitamin B12 for prevention and treatment of anemia in this population group.

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Fig. 1: CONSORT flow diagram depicting overall recruitment, retention, follow-up and endline status of the participants.

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Funding

We are extremely grateful to the Department of Biotechnology, Ministry of Science and Technology, Government of India (vide letter no. BT/PR15606/PFN/20/1188/2015) for providing the financial grant for conducting the study.

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Authors and Affiliations

  1. Departments of Human Nutrition, All India Institute of Medical Sciences, New Delhi, India

    Aakriti Gupta, Ritika Khandelwal & Umesh Kapil

  2. Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India

    Shashi Kant

  3. Cardiac Biochemistry, All India Institute of Medical Sciences, New Delhi, India

    Lakshmy Ramakrishnan

  4. Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India

    Ravindra Mohan Pandey

  5. Department of Pediatrics and Clinical Epidemiology, Sitaram Bhartia Institute of Science and Research, New Delhi, India

    Harshpal Singh Sachdev

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  1. Aakriti Gupta
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Contributions

AG: literature review, content developing, writing the protocol and report, and paper development. SK: literature review, content developing, and writing the protocol. LR: biochemical analysis and interpretation content developing, writing the protocol and report, and paper development. RMP: writing the protocol, data analysis, and interpretation. RK: literature review, content developing, writing the protocol and report, and paper development. UK: literature review, content developing, writing the protocol and report, and paper development and finalization, and will act as guarantor for the paper. HSS: literature review, content developing, writing the protocol and report, and paper development and finalization.

Corresponding author

Correspondence to Umesh Kapil.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Gupta, A., Kant, S., Ramakrishnan, L. et al. Impact of daily-supervised administration of a package of iron and folic acid and vitamin B12 on hemoglobin levels among adolescent girls (12–19 years): a cluster randomized control trial. Eur J Clin Nutr 75, 1588–1597 (2021). https://doi.org/10.1038/s41430-021-00878-6

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