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Community Interventional Trial (CITFOMIST) (CITFOMIST)

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

120 IU milk

200 IU Milk

Non-Fortified Milk

About this trial

This is an interventional diagnostic trial for Vitamin D Deficiency focused on measuring Vitamin D Deficiency, Compliance, Milk

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

EMRI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Male Guidance School

Female Guidance

Male Highschool

Female Highschool

Arm Description

Non-Fortified Milk 120IU Milk 200IU Milk

Non-fortified Milk 120IU Milk 200IU Milk

Non-Fortified Milk 120IU Milk 200IU Milk

Outcomes

Primary Outcome Measures

Compliance with milk consumption

Secondary Outcome Measures

Serum 25(OH)D levels

Full Information

NCT ID

NCT02035423

First Posted

December 10, 2013

Last Updated

January 10, 2014

Sponsor

Tehran University of Medical Sciences

Collaborators

UNICEF

1. Study Identification

Unique Protocol Identification Number

NCT02035423

Brief Title

Community Interventional Trial (CITFOMIST)

Acronym

CITFOMIST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

Collaborators

UNICEF

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

Vitamin D Deficiency, Compliance, Milk

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

6000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Male Guidance School

Arm Type

Active Comparator

Arm Description

Non-Fortified Milk 120IU Milk 200IU Milk

Arm Title

Female Guidance

Arm Type

Active Comparator

Arm Description

Non-fortified Milk 120IU Milk 200IU Milk

Arm Title

Male Highschool

Arm Type

Active Comparator

Arm Description

Non-Fortified Milk 120IU Milk 200IU Milk

Arm Title

Female Highschool

Arm Type

Active Comparator

Arm Description

Non-Fortified Milk 120IU Milk 200IU Milk

Intervention Type

Dietary Supplement

Intervention Name(s)

120 IU milk

Intervention Description

Daily consumption of milk fortified with 120 IU vitamin D

Intervention Type

Dietary Supplement

Intervention Name(s)

200 IU Milk

Intervention Description

Daily Consumption of milk fortified with 200 IU vitamin D

Intervention Type

Dietary Supplement

Intervention Name(s)

Non-Fortified Milk

Intervention Description

Daily consumption of non-fortified milk

Primary Outcome Measure Information:

Title

Compliance with milk consumption

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Serum 25(OH)D levels

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia Khashayar

Organizational Affiliation

Endocrinology and Metabolism Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Abbasali Keshtkar

Organizational Affiliation

Endocrinology and Metabolism Research Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bagher Larijani

Organizational Affiliation

Endocrinology and Metabolism Research Institute

Official's Role

Study Chair

Facility Information:

Facility Name

EMRI

City

Tehran

ZIP/Postal Code

14114

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Community Interventional Trial (CITFOMIST)

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