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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Vitamin D Status
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 585
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute
• Investigators: Study Chair: Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 17, 2009
• First Posted (Estimate): March 18, 2009

Study Record Updates

• Last Update Posted (Estimate): November 21, 2011
• Last Update Submitted That Met QC Criteria: November 12, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: efficacy; vitamin D fortification; milk; orange juice; supplement
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: P/25/47/2027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No