Deficiency, Vitamin DVITDAB_08606NCT00968734
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
A study testing colecalciferol in people with Deficiency, Vitamin D, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Deficiency, Vitamin D
- What is being tested?
- colecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Oct 2009
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Residents of the hospital clinics of Porto Alegre
Who cannot join
- Don't drink milk
- Obesity
- Malnutrition
- Liver disease
- Kidney disease or diabetes
- Use of dietary supplements containing calcium and vitamin D
Show all 10Show fewer
- Medications
- Anticonvulsants
- Barbiturates, or steroids.
- Having performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.
Read the detailed description
Clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin D supplement. Participants were randomly in two groups according to sex and BMI.
In the same date, each group of participants received a meal and dietary supplement of vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples were collected in the seventh and fourteenth day after intake the supplement.
- Conditions
- Deficiency, Vitamin D
- Being tested
- colecalciferol
- Keywords
- Vitamin D, colecalciferol, absorption by Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colecalciferolDietary supplement
50.000UI single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Low fat meal | Experimental | Not described Receives: Dietary Supplement: colecalciferol |
| Hight fat meal | Experimental | Not described Receives: Dietary Supplement: colecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Level of Vitamin D3
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency, Vitamin DStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Investigators
- Fabiana Viegas Raimundo, graduation, Principal investigator, Federal University of Rio Grande do SulTania Weber Furlanetto, PhD, Study director, Federal University of Rio Grande do SulGustavo Faulhaber, Master, Principal investigator, Federal University of Rio Grande do SulRosana Scalco, Master, Principal investigator, Hospital de Clinicas de Porto AlegreLeonardo Marques, Graduation, Principal investigator, Hospital de Clinicas de Porto AlegrePaula Menegatti, Graduation, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968734
- Sponsor's protocol ID
- FIPE, CAPES
- Other IDs
- GPPG_080606
- Acronym
- VITDAB_08606
- Status last verified
- Aug 2009
- First submitted
- 28 Aug 2009
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
- ClinicalTrials.gov ID
- NCT00968734
- Acronym / sponsor ID
- VITDAB_08606 / FIPE, CAPES
- Conditions
- Deficiency, Vitamin D
- Keywords
- Vitamin D, colecalciferol, absorption by Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Aug 2009 (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 purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.
Detailed description
Clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin D supplement. Participants were randomly in two groups according to sex and BMI.
In the same date, each group of participants received a meal and dietary supplement of vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples were collected in the seventh and fourteenth day after intake the supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fat meal | Experimental | Dietary Supplement: colecalciferol |
| Hight fat meal | Experimental | Dietary Supplement: colecalciferol |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Residents of the hospital clinics of Porto Alegre
Key exclusion criteria (10 listed)
- Don't drink milk
- Obesity
- Malnutrition
- Liver disease
- Kidney disease or diabetes
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 |
|---|---|---|
| colecalciferol50.000UI single oral dose | Dietary supplement | Hight fat meal, Low fat meal |
Primary outcome
Serum Level of Vitamin D3
Time frame: 14 days
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 5 Mar 2010.
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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.
Fabiana Viegas Raimundo, graduation principal investigator
Federal University of Rio Grande do Sul
Tania Weber Furlanetto, PhD study director
Federal University of Rio Grande do Sul
Gustavo Faulhaber, Master principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colecalciferol in people with Deficiency, Vitamin D, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 10 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 5 Mar 2010. 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 Brazil. 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?
Serum Level of Vitamin D3 (time frame: 14 days). 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 5 Mar 2010.