Community Interventional Trial (CITFOMIST)

Study Overview
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Brief Summary
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The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

Detailed Description
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The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 international unit (IU) Vit D/1000cc (120IU), milk that contained 1000 IU Vit D /1000cc (200IU)-- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

Official Title
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Community Interventional Trial (CITFOMIST) to Study the Efficacy and Compliance of Different Degrees of Vitamin D Fortified Milk

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: 120 IU milk
* Dietary Supplement: 200 IU Milk
* Dietary Supplement: Non-Fortified Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital Exclusion Criteria: Those taking vitamin D supplements Those with underlying disease affecting bone health Those taking medication affecting bone metabolism Those taking fortified products on a regular basis Those following special diets

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Male Guidance School<br>Non-Fortified Milk 120IU Milk 200IU Milk | Dietary Supplement: 120 IU milk<br>* Daily consumption of milk fortified with 120 IU vitamin D<br>Dietary Supplement: 200 IU Milk<br>* Daily Consumption of milk fortified with 200 IU vitamin D<br>Dietary Supplement: Non-Fortified Milk<br>* Daily consumption of non-fortified milk<br>|
| Active Comparator: Female Guidance<br>Non-fortified Milk 120IU Milk 200IU Milk | Dietary Supplement: 120 IU milk<br>* Daily consumption of milk fortified with 120 IU vitamin D<br>Dietary Supplement: 200 IU Milk<br>* Daily Consumption of milk fortified with 200 IU vitamin D<br>Dietary Supplement: Non-Fortified Milk<br>* Daily consumption of non-fortified milk<br>|
| Active Comparator: Male Highschool<br>Non-Fortified Milk 120IU Milk 200IU Milk | Dietary Supplement: 120 IU milk<br>* Daily consumption of milk fortified with 120 IU vitamin D<br>Dietary Supplement: 200 IU Milk<br>* Daily Consumption of milk fortified with 200 IU vitamin D<br>Dietary Supplement: Non-Fortified Milk<br>* Daily consumption of non-fortified milk<br>|
| Active Comparator: Female Highschool<br>Non-Fortified Milk 120IU Milk 200IU Milk | Dietary Supplement: 120 IU milk<br>* Daily consumption of milk fortified with 120 IU vitamin D<br>Dietary Supplement: 200 IU Milk<br>* Daily Consumption of milk fortified with 200 IU vitamin D<br>Dietary Supplement: Non-Fortified Milk<br>* Daily consumption of non-fortified milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with milk consumption |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25(OH)D levels |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D Deficiency, Compliance, Milk