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Randomised controlled trial analysing supplementation with 250 versus 500 units of vitamin D3, sun exposure and surrounding factors in breastfed infants
  1. Aris Siafarikas1,2,3,4,5,
  2. Helmut Piazena6,
  3. Uwe Feister7,
  4. Max K Bulsara5,8,
  5. Hans Meffert9,
  6. Volker Hesse1,2
  1. 1Sana-Hospital Lichtenberg, Hospital for Children and Adolescent Medicine “Lindenhof”, Academic Teaching Hospital, Charité University Medicine, Humboldt University, Berlin, Germany
  2. 2German Centre for Growth, Development and Preventive Care, Berlin, Germany
  3. 3Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia
  4. 4School of Paediatrics and Child Health, University of Western Australia, Perth, Western Australia, Australia
  5. 5Institute of Health and Rehabilitation Research, University of Notre Dame, Fremantle, Western Australia, Australia
  6. 6Charité—University Medicine Berlin, Group for Medical Photobiology, Berlin, Germany
  7. 7German Meteorological Service, Meteorological Observatory—Richard-Assmann-Observatory Lindenberg, Lindenberg, Germany
  8. 8School of Population Health, University of Western Australia, Perth, Western Australia, Australia
  9. 9Dermatologisches Zentrum Berlin, Berlin, Germany
  1. Correspondence to Dr Aris Siafarikas, Department of Endocrinology and Diabetes, Princess Margaret Hospital, Roberts Road, Subiaco, Perth WA 6008, Australia; aris.siafarikas{at}


Background The rate of non-compliance with vitamin D supplementation is as high as 45%. This is why randomised controlled trials are needed to analyse the response to low doses of vitamin D3.

Objective (1) To compare supplementation with 250 versus 500 units of vitamin D3 and (2) to analyse sun exposure time/ultraviolet B (UVB) exposure during the first 6 weeks of life.

Design 40 breastfed infants (skin photo-types I, II) were recruited in Berlin, Germany (52.5°N), during summer (n=20) and winter (n=20) and randomised into equal groups on either 250 or 500 units of vitamin D3 per day. Outcome measures were: parameters of vitamin D and bone metabolism at delivery and 6 weeks later, sun exposure time, UVB dosimetry and surrounding factors including maternal diet.

Results At delivery 25-hydroxy vitamin D levels were insufficient: 68 (53–83) nmol/l in each group. 6 weeks later levels were sufficient: 139 (114–164) nmol/l on 250 units of vitamin D3 per day and 151 (126–176) nmol/l on 500 units/day. There was no seasonal variation. Daily sun exposure time was 0.4–3.5 h and higher in summer. UVB exposure was 0.01–0.08 minimal erythema dose/day. Calcium levels were within normal.

Conclusions In Berlin, Germany, supplementation with 250 units of vitamin D3 is sufficient for breastfed infants during their first 6 weeks of life in summer and winter. UVB exposure is very low throughout the year.

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  • Funding Northern German Society of Paediatric and Adolescent Medicine.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the Ethics Committee, Charité University Hospital, Berlin, Germany.

  • Provenance and peer review Not commissioned; externally peer reviewed.