Randomised controlled trial analysing supplementation with 250 versus 500 units of vitamin D3, sun exposure and surrounding factors in breastfed infants

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 degrees 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.