Effect of high-dose vitamin D supplementation on radiographically detectable bone disease of very low birth weight infants.

To test the hypothesis that high-dose vitamin D2 supplementation would result in a lower incidence of radiographically detectable bone disease, we randomly assigned 40 very low birth weight infants to a control group who received vitamin D2 in a dosage of 400 IU/day and 41 to an experimental group who received a dosage of 2000 IU/day. After 6 weeks, radiographs from all infants were scored blindly for degree of radiographic bone disease, and serum osteocalcin and 25-hydroxyvitamin D levels were measured. Mean vitamin D intake was 360 +/- 141 (SD) IU/day in the control group and 2170 +/- 144 (SD) IU/day in the experimental group. Median 6-week serum 25-hydroxyvitamin D levels were 24 ng/ml (range 3 to 60 ng/ml) in the control group and 68 ng/ml (range 9 to 150 ng/ml) in the experimental group (p less than 0.001). Overall, 20% of the infants had evidence of moderate radiographic bone disease and only 2% were severely affected. The radiographic bone score (median = 2.5) and serum osteocalcin concentration (mean = 21.7 +/- 8.7 ng/ml) in the control subjects did not differ significantly from those in the experimental group (median bone score = 2.0; mean osteocalcin level = 24.1 +/- 7.9 ng/ml). Although there may be a subset of very low birth weight infants who would benefit from high doses of vitamin D, we conclude that no generalized clinical improvement can be attributed to this regimen alone.

RCT Entities:   Population Interventions Outcomes