Community Interventional Trial (CITFOMIST)

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: 120 IU milk; Dietary Supplement: 200 IU Milk; Dietary Supplement: Non-Fortified Milk

• Registration Number: NCT02035423
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Study First Submitted: 2013-12-10
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-10
• Last Update Submitted: 2014-01-10
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Male Guidance School	200 IU Milk	Non-Fortified Milk 120IU Milk 200IU Milk
Male Guidance School	Non-Fortified Milk	Non-Fortified Milk 120IU Milk 200IU Milk
Female Guidance	120 IU milk	Non-fortified Milk 120IU Milk 200IU Milk
Male Guidance School	120 IU milk	Non-Fortified Milk 120IU Milk 200IU Milk
Female Guidance	200 IU Milk	Non-fortified Milk 120IU Milk 200IU Milk
Female Guidance	Non-Fortified Milk	Non-fortified Milk 120IU Milk 200IU Milk
Male Highschool	120 IU milk	Non-Fortified Milk 120IU Milk 200IU Milk
Male Highschool	200 IU Milk	Non-Fortified Milk 120IU Milk 200IU Milk
Male Highschool	Non-Fortified Milk	Non-Fortified Milk 120IU Milk 200IU Milk
Female Highschool	120 IU milk	Non-Fortified Milk 120IU Milk 200IU Milk
Female Highschool	200 IU Milk	Non-Fortified Milk 120IU Milk 200IU Milk
Female Highschool	Non-Fortified Milk	Non-Fortified Milk 120IU Milk 200IU Milk

Primary Outcome Measures

Name	Time	Method
Compliance with milk consumption	1 month

Secondary Outcome Measures

Name	Time	Method
Serum 25(OH)D levels	1 month

Trial Locations

Locations (1)

EMRI; 🇮🇷 Tehran, Iran, Islamic Republic of