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Efficacy of Daily Supplementation of Milk Fortified With Vitamin D2 for Three Months in Healthy School Children: A Randomized Placebo Controlled Trial

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Abstract

Objective

To evaluate the efficacy of daily supplementation of 200 mL milk fortified with 240 IU of vitamin D2 (ergocalciferol).

Design

Double-blind randomized controlled trial.

Settings

School-based study in Delhi between October and December, 2019.

Participants

235 healthy children aged 10–14 years.

Intervention

Daily supplementation of 200 mL milk fortified with 240 IU of ergocalciferol in intervention group (n=119) and 200 mL of plain milk in control group (n =116) for 3 months.

Outcome Measures

Change in serum 25 hydroxy vitamin D (25(OH)D), parathyroid hormone (PTH), bone formation and resorption markers, and urinary calcium creatinine ratio (U-Ca/CrR).

Results

The mean (SD) baseline serum 25(OH) D level in control and fortification groups was 11.9 (3.8) and 11.4 (3.6) ng/mL (P=0.23), respectively. The serum 25(OH)D levels did not increase post-intervention with the dose used for fortification, but were significantly higher in intervention group as compared to control group [10.8 (3.4) vs 6.7 (3.5) ng/mL; P<0.001]. A higher proportion of secondary hyperparathyroidism was observed post-intervention in control (39%) than in intervention group (13.3%); P<0.001. Serum carboxy-terminal telopeptide levels were similar in both groups but the serum procollagen type1 N-terminal propeptide levels were higher in the control than intervention group (P<0.007), following supplementation.

Conclusion

Supplementation of milk fortified with approximately 240 IU vitamin D2 for three months did not achieve sufficient serum 25(OH)D levels in Indian children with vitamin D deficiency during winter.

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Acknowledgements

Ms Pamela Marwaha for complete supervision of the project and Akanksha Chand for collection of dietary data. Mother Dairy Fruit and Vegetables Private Ltd for providing Tetra packs of milk at concessional rate for the study.

Author information

Authors and Affiliations

  1. Society for Endocrine Health Care of Elderly, Adolescents and Children (SEHEAC), Flat no. 17, Gautam Apartments, Gautam Nagar, New Delhi, 110 049, India

    Raman Kumar Marwaha

  2. Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India

    Aashima Dabas & Sangeeta Yadav

  3. Food and Nutrition, Institute of Home Economics, University of Delhi, Delhi, India

    Seema Puri

  4. Orthopedics, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India

    Vineet Dabas

  5. Biostatistics, All India Institute of Medical Sciences, New Delhi, India

    Mani Kalaivani

  6. Dr Dangs Lab, New Delhi, India

    Arjun Dang

  7. Biochemistry Division, Indian Council of Medical Research, National Institute of Nutrition, Hyderabad, India

    R. Pullakhandam

  8. Endocrinology, Sanjay Gandhi Post Graduate Institute, Lucknow, India

    Sushil Gupta

  9. Homeopathy, BR Sur Homeopathic college, New Delhi, India

    Archana Narang

Authors
  1. Raman Kumar Marwaha
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  2. Aashima Dabas
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Corresponding author

Correspondence to Raman Kumar Marwaha.

Additional information

Ethics clearance

Institutional Ethics Committee, Maulana Azad Medical College; No. F.1/MAMC/IEC/(68/03/2019)/No 153, dated 09 August, 2019.

Contributors

RKM: conceptualizing and designing the study, clinical evaluation and preparation of the manuscript; AD,VD: clinical evaluation, analysis of data and preparation of manuscript; SY: designing the study and preparation of manuscript; SP: designing of dietary proforma, analysis of dietary data, manuscript preparation; AD: (Arjun Dang) Biochemical and hormonal evaluation, manuscript review; KV: sample size calculation and statistical analysis, manuscript preparation; PR: conceptualization and preparation of manuscript; SG: analysis of bone markers, manuscript review; AN: sample and data collection and data entry, manuscript review. All authors have read and approved the final manuscript.

Funding

The Initiative Nutrition of India (TINI) to Society for Endocrine Health Care of Elderly, Adolescents and Children (SEHEAC) (RKM).

Competing interest

None stated.

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Cite this article

Marwaha, R.K., Dabas, A., Puri, S. et al. Efficacy of Daily Supplementation of Milk Fortified With Vitamin D2 for Three Months in Healthy School Children: A Randomized Placebo Controlled Trial. Indian Pediatr 58, 820–825 (2021). https://doi.org/10.1007/s13312-021-2300-9

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  • DOI: https://doi.org/10.1007/s13312-021-2300-9

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