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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00864539
Other study ID # P/25/47/2027
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 17, 2009
Last updated November 12, 2011
Start date November 2007
Est. completion date June 2010

Study information

Verified date November 2011
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 585
Est. completion date June 2010
Est. primary completion date February 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 11 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
fortified milk
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
fortified orange juice
daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package
plain orange juice
daily intake of 250 ml plain orange juice
calcium-vitamin D supplement
daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)
Placebo
daily placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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