Severe vitamin D deficiency in mothers and their breastfed infants is a significant health problem in the Middle East. Supplementation of the breastfed infant alone with the recommended dose of vitamin D may be insufficient in high-risk population. We investigated the effect of combined maternal and infant vitamin D supplementation on vitamin D status of the breastfed infant. We examined also the effect of supplementation on vitamin D antirachitic activity of breast milk in a subset of mothers. Healthy breastfeeding mothers (n = 90) were randomly assigned to 2000 IU daily (group 1) or 60,000 IU monthly (group 2) of vitamin D(2), and all their infants (n = 92) received 400 IU daily of vitamin D(2) for 3 months. Most infants had vitamin D deficiency - 25-hydroxyvitamin D [25(OH)D] <or= 37.5 nmol L(-1)- at study entry. Serum 25(OH)D concentrations at 3 months increased significantly from baseline in infants of mothers in group 1 (13.9 +/- 8.6 vs. 49.6 +/- 18.5 nmol L(-1), P < 0.0001) and group 2 (13.7 +/- 12.1 vs. 44.6 +/- 15.0 nmol L(-1), P < 0.0001). Maternal and infant serum 25(OH)D concentrations correlated positively at baseline (r = 0.36, P = 0.01) and 3 months (r = 0.46, P = 0.002). Milk antirachitic activity increased from undetectable (<20 IU L(-1)) to a median of 50.9 IU L(-1). In conclusion, combined maternal and infant vitamin D supplementation was associated with a threefold increase in infants' serum 25(OH)D concentrations and a 64% reduction in the prevalence of vitamin D deficiency without causing hypervitaminosis D.