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Community Interventional Trial (CITFOMIST) (CITFOMIST)

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ClinicalTrials.gov Identifier: NCT02035423
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
UNICEF
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: 120 IU milk Dietary Supplement: 200 IU Milk Dietary Supplement: Non-Fortified Milk Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Community Interventional Trial (CITFOMIST) to Study the Efficacy and Compliance of Different Degrees of Vitamin D Fortified Milk
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Compliance with milk consumption [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Serum 25(OH)D levels [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035423


Locations
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Iran, Islamic Republic of
EMRI
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
UNICEF
Investigators
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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
More Information
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02035423    
Other Study ID Numbers: EMRI-1390
CITFOMIST ( Other Identifier: EMRI )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Tehran University of Medical Sciences:
Vitamin D Deficiency
Compliance
Milk
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders