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Trial record 17 of 5632 for:    dietary supplements

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014