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NCT00864539

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

NCT ID: NCT00864539

Last Updated: 2011-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

585 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vitamin D Status Healthy

Keywords

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vitamin D fortification milk orange juice supplement efficacy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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fortified milk

daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL

Group Type EXPERIMENTAL

fortified milk

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

plain milk

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

fortified orange juice

Intervention Type DIETARY_SUPPLEMENT

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

plane juice

subjects receiving plain orange juice

Group Type ACTIVE_COMPARATOR

plain orange juice

Intervention Type DIETARY_SUPPLEMENT

daily intake of 250 ml plain orange juice

vitamin D-Ca supplement

Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D

Group Type EXPERIMENTAL

calcium-vitamin D supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Subjects receiving daily placebo containing 1g starch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

daily placebo

Interventions

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fortified milk

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

Intervention Type DIETARY_SUPPLEMENT

plain milk

daily intake of 200 ml plain milk

Intervention Type DIETARY_SUPPLEMENT

fortified orange juice

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

Intervention Type DIETARY_SUPPLEMENT

plain orange juice

daily intake of 250 ml plain orange juice

Intervention Type DIETARY_SUPPLEMENT

calcium-vitamin D supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

daily placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FM PM FJ PJ SP PL

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Tirang R. Neyestani

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tirang R. Neyestani, Ph.D.

Role: STUDY_CHAIR

National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741

Other Identifiers

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P/25/47/2027

Identifier Type: -

Identifier Source: org_study_id