Abstract
Background/Objective:
To study whether a free supply of vitamin D2 drops to 6-week-old infants together with tailor-made information handouts improves the vitamin D status after 7 weeks in the intervention group compared to a control group.
Subjects/Methods:
In this cluster randomized controlled trial in eight child health clinics in Oslo, Norway, 66 healthy infants with Pakistani, Turkish or Somali background were included. The intervention group received daily supplementation of vitamin D drops containing 10 μg (400 IU) of ergocalciferol (vitamin D2) with a tailor-made information brochure about vitamin D and its sources, and instruction on how to administer the drops. They were compared to a control group receiving usual care. The principal outcome measure was increase in serum 25-hydroxyvitamin D (S-25OHD) 7 weeks later. S-25OHD was analyzed by high-performance liquid chromatography-ultraviolet-mass spectrometry.
Results:
Total 78% (n=51) of the included infants completed the study. At follow-up, S-25OHD was significantly higher in the intervention group than in the control group (93.5 versus 72.7 nmol l−1, P=0.03). The mean increase in S-25OHD adjusted for baseline was 28 nmol l−1 (95% confidence interval 10.9–45.2, P=0.002) higher in the intervention group than in the control group. Among exclusively breastfed infants at baseline, S-25OHD increased by 32.3 nmol l−1 (P=0.035) in the intervention group compared to control group.
Conclusion:
Free supply of vitamin D drops to 6-week-old infants together with tailor-made information handouts significantly improved the vitamin D status of infants with immigrant background compared to usual care.
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Acknowledgements
We thank all mothers, health visitors and members of the study advisory group Leif Brunvand, Aud Haugen, Else-Karin Grøholt and Kirsten Berge, our child health clinics coordinator, for their help with the study. We also thank Magne Thoresen, University of Oslo for conducting the independent statistical analysis of the primary outcomes. This study was funded by the Directorate for Health and Social Affairs. The views and opinions expressed do not necessarily reflect those of the Directorate for Health and Social Affairs.
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Guarantor: HE Meyer.
Contributors: AAM carried out the data collection, performed data analysis and prepared the manuscript. HEM developed the study protocol, secured initial funding and assisted in the analysis of the data. K-IK and HEM supervised the study. All authors commented on the draft, contributed to the interpretation of the findings and approved the final version of the manuscript.
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Madar, A., Klepp, KI. & Meyer, H. Effect of free vitamin D2 drops on serum 25-hydroxyvitamin D in infants with immigrant origin: a cluster randomized controlled trial. Eur J Clin Nutr 63, 478–484 (2009). https://doi.org/10.1038/sj.ejcn.1602982
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DOI: https://doi.org/10.1038/sj.ejcn.1602982