To assess the efficacy and acceptability of vitamin D-fortified Liquid
milli in the management of hypovitaminosis D we carried out a double-
blind, randomized, controlled trial on 51 community-based, elderly sub
jects with serum 25 hydroxyvitamin D (25OHD) levels of less than 12.9
ng/ml (normal range 10-80 ng/ml). Each subject had a dietary assessmen
t, mental test score, outdoor score, serum 25 hydroxyvitamin D level,
and a general biochemical screening at baseline in April 1993 which wa
s repeated in September 1993, April 1994, and September 1994. All subj
ects received 500 mi of milk per day, delivered to their homes in spec
ially manufactured, blank, tetrapak cartons, from June 1993 to June 19
94: 23 subjects received unfortified milk (control group) and 28 subje
cts received fortified milk (active,group). Our results showed a basel
ine mean 25OHD level in the active group of 9.6 (range < 5.5-12.7) ng/
ml and in the control group of 10.0 (range < 5.5-12.9) ng/ml (P < 0.4)
. One year later the mean 25OHD level in the active,group had risen si
gnificantly from its baseline to 18.5 (range 9.6-26.7) ng/ml (P < 0.00
1) and was significantly different from the control,group with a 1-yea
r mean of 12.7 (range < 4-24.1) ng/ml (P < 0.001). Serum calcium level
s in the active group also showed a significant rise over the 1-year p
eriod (P < 0.001) whereas those in the control group did not. We concl
ude that vitamin D-fortified liquid milk is a safe, effective, and acc
eptable method of administering vitamin D to the elderly, community-ba
sed population.