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Completed

NCT Number: NCT00864539

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

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Key information

Conditions

Vitamin D Status Healthy

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortified Milk

Dietary Supplement

daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks

Other names: FM

Plain Milk

Dietary Supplement

daily intake of 200 ml plain milk

Other names: PM

fortified orange juice

Dietary Supplement

daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package

Other names: FJ

plain orange juice

Dietary Supplement

daily intake of 250 ml plain orange juice

Other names: PJ

calcium-vitamin D supplement

Dietary Supplement

daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)

Other names: SP

Placebo

Dietary Supplement

daily placebo

Other names: PL

Primary outcomes

  1. Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group

    Time frame: 10 weeks

    Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 18, 2009
Registry last updated
Nov 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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