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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864539
• Other study ID #: P/25/47/2027
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 17, 2009
• Last updated: November 12, 2011
• Start date: November 2007
• Est. completion date: June 2010

Study information

• Verified date: November 2011
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: June 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Vitamin D Status

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes