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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tirang R. Neyestani, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT00864539
First received: March 17, 2009
Last updated: November 12, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitamin D Status
Healthy
 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
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Nutrition and Food Technology Institute:

Primary Outcome Measures:
  • Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.


Enrollment: 585
Study Start Date: November 2007
Study Completion Date: June 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: FM
Active Comparator: plain milk
daily intake of 200 mL plain milk
 Dietary Supplement: plain milk
daily intake of 200 ml plain milk
Other Name: 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 Name: FJ
Active Comparator: plane juice
subjects receiving plain orange juice
 Dietary Supplement: plain orange juice
daily intake of 250 ml plain orange juice
Other Name: 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 Name: SP
Placebo Comparator: Placebo
Subjects receiving daily placebo containing 1g starch
 Dietary Supplement: Placebo
daily placebo
Other Name: PL

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.

  Eligibility

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864539

Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT00864539     History of Changes
Other Study ID Numbers: P/25/47/2027
Study First Received: March 17, 2009
Results First Received: July 27, 2010
Last Updated: November 12, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by National Nutrition and Food Technology Institute:
vitamin D fortification
milk
orange juice
supplement
efficacy

Additional relevant MeSH terms:
Calcium, Dietary
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013