Vitamin D DeficiencyCITFOMISTNCT02035423
Community Interventional Trial (CITFOMIST)
A study testing 120 IU milk, 200 IU Milk and Non-Fortified Milk in people with Vitamin D Deficiency, run by Tehran University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- 120 IU milk, 200 IU Milk and Non-Fortified Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- 120 IU milk, 200 IU Milk, Non-Fortified Milk
- Keywords
- Vitamin D Deficiency, Compliance, Milk
- Medical subject headings
- Vitamin D Deficiency, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
120 IU milkDietary supplement
Daily consumption of milk fortified with 120 IU vitamin D
200 IU MilkDietary supplement
Daily Consumption of milk fortified with 200 IU vitamin D
Non-Fortified MilkDietary supplement
Daily consumption of non-fortified milk
| Study group | Role | What they receive |
|---|---|---|
| Male Guidance School | Active comparator | Non-Fortified Milk 120IU Milk 200IU Milk Receives: Dietary Supplement: 120 IU milk; Dietary Supplement: 200 IU Milk; Dietary Supplement: Non-Fortified Milk |
| Female Guidance | Active comparator | Non-fortified Milk 120IU Milk 200IU Milk Receives: Dietary Supplement: 120 IU milk; Dietary Supplement: 200 IU Milk; Dietary Supplement: Non-Fortified Milk |
| Male Highschool | Active comparator | Non-Fortified Milk 120IU Milk 200IU Milk Receives: Dietary Supplement: 120 IU milk; Dietary Supplement: 200 IU Milk; Dietary Supplement: Non-Fortified Milk |
| Female Highschool | Active comparator | Non-Fortified Milk 120IU Milk 200IU Milk Receives: Dietary Supplement: 120 IU milk; Dietary Supplement: 200 IU Milk; Dietary Supplement: Non-Fortified Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with milk consumption
Measured: 1 month
Secondary outcomes (1)
Serum 25(OH)D levels
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Sponsor
- Investigators
- Patricia Khashayar, Principal investigator, Endocrinology and Metabolism Research InstituteAbbasali Keshtkar, Study director, Endocrinology and Metabolism Research InstituteBagher Larijani, Study chair, Endocrinology and Metabolism Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035423
- Sponsor's protocol ID
- EMRI-1390
- Other IDs
- CITFOMIST
- Acronym
- CITFOMIST
- Status last verified
- Jan 2014
- First submitted
- 10 Dec 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Interventional Trial (CITFOMIST) to Study the Efficacy and Compliance of Different Degrees of Vitamin D Fortified Milk
- ClinicalTrials.gov ID
- NCT02035423
- Acronym / sponsor ID
- CITFOMIST / EMRI-1390
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Deficiency, Compliance, Milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male Guidance School | Active comparator | Dietary Supplement: 120 IU milk, Dietary Supplement: 200 IU Milk, Dietary Supplement: Non-Fortified MilkNon-Fortified Milk 120IU Milk 200IU Milk |
| Female Guidance | Active comparator | Dietary Supplement: 120 IU milk, Dietary Supplement: 200 IU Milk, Dietary Supplement: Non-Fortified MilkNon-fortified Milk 120IU Milk 200IU Milk |
| Male Highschool | Active comparator | Dietary Supplement: 120 IU milk, Dietary Supplement: 200 IU Milk, Dietary Supplement: Non-Fortified MilkNon-Fortified Milk 120IU Milk 200IU Milk |
| Female Highschool | Active comparator | Dietary Supplement: 120 IU milk, Dietary Supplement: 200 IU Milk, Dietary Supplement: Non-Fortified MilkNon-Fortified Milk 120IU Milk 200IU Milk |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 120 IU milkDaily consumption of milk fortified with 120 IU vitamin D | Dietary supplement | Female Guidance, Female Highschool, Male Guidance School, Male Highschool |
| 200 IU MilkDaily Consumption of milk fortified with 200 IU vitamin D | Dietary supplement | Female Guidance, Female Highschool, Male Guidance School, Male Highschool |
| Non-Fortified MilkDaily consumption of non-fortified milk | Dietary supplement | Female Guidance, Female Highschool, Male Guidance School, Male Highschool |
Primary outcome
Compliance with milk consumption
Time frame: 1 month
1 secondary outcome
Serum 25(OH)D levels
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Khashayar principal investigator
Endocrinology and Metabolism Research Institute
Abbasali Keshtkar study director
Endocrinology and Metabolism Research Institute
Bagher Larijani study chair
Endocrinology and Metabolism Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 120 IU milk, 200 IU Milk and Non-Fortified Milk in people with Vitamin D Deficiency, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with milk consumption (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.