Community Interventional Trial (CITFOMIST)

Vitamin D Deficiency Clinical Trial

— CITFOMIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035423
• Other study ID #: EMRI-1390
• Secondary ID: CITFOMIST
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: January 10, 2014
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 19 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• 120 IU milk
Daily consumption of milk fortified with 120 IU vitamin D
• 200 IU Milk
Daily Consumption of milk fortified with 200 IU vitamin D
• Non-Fortified Milk
Daily consumption of non-fortified milk

Locations

Country	Name	City	State
Iran, Islamic Republic of	EMRI	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	UNICEF

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with milk consumption		1 month	No
Secondary	Serum 25(OH)D levels		1 month	No