- The
study subjects were derived from four high schools local to the area
of the study. 112 female subjects aged 11.9 +/- 0.5 years were selected
for participation in the study. Patients included in the study were
premenarchal, caucasian, between 80-120% of ideal body weight for height,
had no known eating disorders, took no medication regularly, and had
no medical disorders known to affect bone development.1
- Subjects
were assigned by stratified randomization, which balanced the groups
with respect to BMI and lumbosacral bone mineral density (LSBMD), to
receive daily supplementation of either 500 mg Calcium Citrate Malate
supplementation or placebo.
- At
the beginning of the study and q 6 months through the 18-month study,
x-ray absorptiometry was used to measure total body bone mineral density
and content as well as lumbar spine bone mineral density and content.
The two groups were, as above, balanced with respect to LSBMD at baseline.
- The
treatment group's total calcium intake (~110% of the minimum RDA) was
significantly greater than that of the control group (~ 80 % of the
minimum RDA).
- Over
the course of the study, the supplemented group, when compared with
the placebo group, had significantly greater increases in lumbar spine
bone mineral density and content (18.7% versus 15.8%, P value =0.03),
and also in total body bone mineral density (39.4% versus 34.7%, P value
= 0.05).
- Adverse
effects of the supplementation are not mentioned in the study, although
of the 18 original subjects who were randomized but did not complete
the study; the reason for this was aversion to taking a daily pill.
- The
study appears to be valid, although it is not clear whether the outcome
assessors were blinded.
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