Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Prevalence of Vitamin D Insufficiency in Primary School Children and Comparison of the Effect of Calcium-Vitamin D-Fortified Milk, -Orange Juice and Calcium-Vitamin D Supplement

Conditions
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Vitamin D Status, Healthy

Intervention / Treatment
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* Dietary Supplement: fortified milk
* Dietary Supplement: plain milk
* Dietary Supplement: fortified orange juice
* Dietary Supplement: plain orange juice
* Dietary Supplement: calcium-vitamin D supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 9-11 years Being healthy (no apparent clinical disease) Informed consent signed by child's parent(s) Exclusion Criteria: Subjects receiving vitamin D, calcium or omega-3 supplement Unwillingness to continue the study Subjects with type 1 diabetes, allergy, kidney disorders

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fortified milk<br>daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL | Dietary Supplement: fortified milk<br>* daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks<br>* Other names: FM;|
| Active Comparator: plain milk<br>daily intake of 200 mL plain milk | Dietary Supplement: plain milk<br>* daily intake of 200 ml plain milk<br>* Other names: PM;|
| Experimental: fortified orange juice<br>daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium | Dietary Supplement: fortified orange juice<br>* daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package<br>* Other names: FJ;|
| Active Comparator: plane juice<br>subjects receiving plain orange juice | Dietary Supplement: plain orange juice<br>* daily intake of 250 ml plain orange juice<br>* Other names: PJ;|
| Experimental: vitamin D-Ca supplement<br>Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D | Dietary Supplement: calcium-vitamin D supplement<br>* daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)<br>* Other names: SP;|
| Placebo Comparator: Placebo<br>Subjects receiving daily placebo containing 1g starch | Dietary Supplement: Placebo<br>* daily placebo<br>* Other names: PL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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milk, vitamin D fortification, orange juice, supplement, efficacy