Community Interventional Trial (CITFOMIST) (CITFOMIST)

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: 120 IU milk; Dietary supplement: 200 IU Milk; Dietary supplement: Non-Fortified Milk

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 Type: Interventional
• Enrollment (Actual): 6000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 14114
    • EMRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compliance with milk consumption	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Collaborators: UNICEF
• Investigators: Principal Investigator: Patricia Khashayar, Endocrinology and Metabolism Research Institute; Study Director: Abbasali Keshtkar, Endocrinology and Metabolism Research Institute; Study Chair: Bagher Larijani, Endocrinology and Metabolism Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Compliance; Vitamin D Deficiency; Milk
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: EMRI-1390; CITFOMIST (Other Identifier: EMRI)