This study is conducted in two phases. At the first phase, the prevalence of vitamin D insufficiency in primary school-children in Tehran is determined during the cold seasons of 2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is compared in six selected primary schools.
At the first step, serum 25-(OH)D, PTH(parathyroid hormone), osteocalcin, bone alkaline phosphatase, calcium, phosphorous, and magnesium is evaluated. Anthropometric and dietary intake data is also collected. In the second phase, we have 6 experimental groups: (1) plain milk; (2) calcium-vitamin D-fortified milk (containing 500 mg Ca and 100 IU vitamin D/200 mL package); (3) plain orange juice; (4) fortified orange juice containing equal amounts of calcium and vitamin D as fortified milk; (5) calcium-vitamin D supplement (500 mg calcium and 200 IU vitamin D); and (6) placebo. Each group consists of 40-60 children (9-11 years) from both sexes. All above-mentioned biochemical, anthropometric and dietary intake data is collected both in the beginning and in the end of interventional period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
585
daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks
daily intake of 200 ml plain milk
daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package
Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group
Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.
Time frame: 10 weeks
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daily intake of 250 ml plain orange juice
daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)
daily placebo