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

Phase 2

Completed

• Conditions: Vitamin D Status; Healthy
• Interventions: 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

• Registration Number: NCT00864539
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

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

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2009-02
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Study Completion: 2010-06
• Results First Submitted: 2010-07-27
• Results First Submitted QC: 2010-09-07
• Results First Posted: 2010-09-28
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-12
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fortified milk	fortified milk	daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL
plain milk	plain milk	daily intake of 200 mL plain milk
fortified orange juice	fortified orange juice	daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
plane juice	plain orange juice	subjects receiving plain orange juice
vitamin D-Ca supplement	calcium-vitamin D supplement	Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
Placebo	Placebo	Subjects receiving daily placebo containing 1g starch

Primary Outcome Measures

Name	Time	Method
Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group	10 weeks	Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.