25-hydroxyvitamin D Serum ConcentrationsPhase 3NCT01909622
Trial of Vitamin D Fortified Milk
A Phase 3 study testing Vitamin D and No vitamin D in people with 25-hydroxyvitamin D Serum Concentrations, run by University of Michigan at 2 sites in Colombia.
Trial summary
Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not been suspected before. The most cost-effective method for reducing population-wide VDD is through fortification of commonly consumed foods. Read more about this study
- Who is it for?
- Ages 144 to 174 months
- Conditions the study is for
- 25-hydroxyvitamin D Serum Concentrations
- What is being tested?
- Vitamin D and No vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesColombia
- Study dates
- Jun 2013to Oct 2016
- Phase
- Phase 3
- 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 144 to 174 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 144 and 174 completed months by the time of enrollment.
- Intention to stay in the city for the next six weeks.
- Children living with their biological mothers.
- Families own a refrigerator.
Who cannot join
- History of illness involving calcium or bone metabolism, including stones of the urinary tract.
- Currently taking vitamin D supplements as treatment of any disease.
- Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year.
- Known history of lactose intolerance or other contra-indications or aversion to milk intake.
- Known hypercalcemia.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
FINUSAD - Foundation for Research in Nutrition and Health
Bogotá
University of La Sabana
Chía
About this study
Official title: A Randomized Trial of Milk Fortified With Vitamin D in Colombia
Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not been suspected before. The most cost-effective method for reducing population-wide VDD is through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification varies by dose, duration, and population characteristics; and it is currently unknown whether it could be an efficacious public health intervention to curb the VDD epidemic among children living in tropical areas. We propose to conduct a randomized, controlled, double blind trial to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families with a child participating in an ongoing cohort study will be randomized to receive one liter per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim milk for a six-week period. Caregivers will be instructed to give the index child two cups of milk per day and to distribute the remaining milk to the rest of the family. We will measure serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the intervention period.
- Conditions
- 25-hydroxyvitamin D Serum Concentrations
- Being tested
- Vitamin D, No vitamin D
- Keywords
- Vitamin D, Milk fortification, Children, Colombia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
No vitamin DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D-fortified milk | Experimental | Skim milk fortified with 600 IU vitamin D3 / 250 mL Receives: Dietary Supplement: Vitamin D |
| Vitamin D-unfortified milk | Active comparator | Unfortified skim milk Receives: Dietary Supplement: No vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of 25-OH vitamin D
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 25-hydroxyvitamin D Serum ConcentrationsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Villamor, University of Michigan
- Investigators
- Mercedes Mora, MSc, RD, Study director, FINUSAD - Foundation for Research in Nutrition and HealthHenry Oliveros, MD, MSc, Study director, University of La SabanaEduardo Villamor, MD, DrPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909622
- Sponsor's protocol ID
- VDFORT
- Status last verified
- Oct 2016
- First submitted
- 24 Jul 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Milk Fortified With Vitamin D in Colombia
- ClinicalTrials.gov ID
- NCT01909622
- Acronym / sponsor ID
- VDFORT
- Conditions
- 25-hydroxyvitamin D Serum Concentrations
- Keywords
- Vitamin D, Milk fortification, Children, Colombia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Jul 2013 (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.
Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not been suspected before. The most cost-effective method for reducing population-wide VDD is through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification varies by dose, duration, and population characteristics; and it is currently unknown whether it could be an efficacious public health intervention to curb the VDD epidemic among children living in tropical areas. We propose to conduct a randomized, controlled, double blind trial to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families with a child participating in an ongoing cohort study will be randomized to receive one liter per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim milk for a six-week period. Caregivers will be instructed to give the index child two cups of milk per day and to distribute the remaining milk to the rest of the family. We will measure serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D-fortified milk | Experimental | Dietary Supplement: Vitamin DSkim milk fortified with 600 IU vitamin D3 / 250 mL |
| Vitamin D-unfortified milk | Active comparator | Dietary Supplement: No vitamin DUnfortified skim milk |
Who may qualify
- Ages
- 144 to 174 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 144 and 174 completed months by the time of enrollment.
- Intention to stay in the city for the next six weeks.
- Children living with their biological mothers.
- Families own a refrigerator.
Key exclusion criteria (5 listed)
- History of illness involving calcium or bone metabolism, including stones of the urinary tract.
- Currently taking vitamin D supplements as treatment of any disease.
- Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year.
- Known history of lactose intolerance or other contra-indications or aversion to milk intake.
- Known hypercalcemia.
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 |
|---|---|---|
| Vitamin D | Dietary supplement | Vitamin D-fortified milk |
| No vitamin D | Dietary supplement | Vitamin D-unfortified milk |
Primary outcome
Serum concentrations of 25-OH vitamin D
Time frame: up to 6 weeks
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 27 Oct 2016.
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.
Mercedes Mora, MSc, RD study director
FINUSAD - Foundation for Research in Nutrition and Health
Henry Oliveros, MD, MSc study director
University of La Sabana
Eduardo Villamor, MD, DrPH principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D and No vitamin D in people with 25-hydroxyvitamin D Serum Concentrations, run by University of Michigan at 2 sites in Colombia.
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 4 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum concentrations of 25-OH vitamin D (time frame: up to 6 weeks). 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 27 Oct 2016.