NCT00864539

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 585 (actual)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vitamin D Status
• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	fortified milk	daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks
DIETARY_SUPPLEMENT	plain milk	daily intake of 200 ml plain milk
DIETARY_SUPPLEMENT	fortified orange juice	daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package
DIETARY_SUPPLEMENT	plain orange juice	daily intake of 250 ml plain orange juice
DIETARY_SUPPLEMENT	calcium-vitamin D supplement	daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)
DIETARY_SUPPLEMENT	Placebo	daily placebo

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-02-01
• Completion: 2010-06-01
• First posted: 2009-03-18
• Last updated: 2011-11-21
• Results posted: 2010-09-28