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Completed

NCT Number: NCT02035423

Community Interventional Trial (CITFOMIST)

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Behavior Deficiency Diseases Health Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EMRI

Tehran, 14114, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

120 IU milk

Dietary Supplement

Daily consumption of milk fortified with 120 IU vitamin D

200 IU Milk

Dietary Supplement

Daily Consumption of milk fortified with 200 IU vitamin D

Non-Fortified Milk

Dietary Supplement

Daily consumption of non-fortified milk

Primary outcomes

  1. Compliance with milk consumption

    Time frame: 1 month

Secondary outcomes

  1. Serum 25(OH)D levels

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • UNICEF

Registry information

Official study title

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

Acronym: CITFOMIST

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 14, 2014
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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