Vitamin D DeficiencyVITD_100484NCT01519986
The Effect of Fat on Vitamin D Absorption
A study testing Vitamin D3 in people with Vitamin D Deficiency, run by Federal University of Rio Grande do Sul.
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 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Oct 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- 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.
About this study
Official title: The Effect of Fat on Vitamin D Absorption After a Single Oral Dose
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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D, Cholecalciferol, Supplementation, Dietary Supplements, Dietary Fats, 25-hydroxyvitamin 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.
Vitamin D3Dietary supplement
Supplement of vitamin D3
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low fat Meal | Experimental | 50,000 UI vitamin D3 with low fat meal Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo |
| Medium fat meal | Experimental | 50,000 UI vitamin D3 with medium fat meal Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo |
| High fat meal | Experimental | 50,000 UI vitamin D3 with high fat meal Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum 25(OH)D at 14 day after intervention
25(OH)D response to supplemental vitamin D3
Measured: Change from baseline in serum 25(OH)D at 14 days
Secondary outcomes (1)
Change from baseline in Parathyroid hormone at 14 days after intervention
Parathyroid hormone response to supplemental vitamin D3
Measured: Change from baseline in Parathyroid hormone at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Fabiana Viegas Raimundo, Federal University of Rio Grande do Sul
- Investigators
- Tania W Furlanetto, PhD, Principal investigator, Federal University of Health Science of Porto AlegreGustavo AM Faulhaber, PhD, Study chair, Federal University of Health Science of Porto AlegreFabiana V Raimundo, MD, Study chair, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519986
- Sponsor's protocol ID
- VITD_100484
- Acronym
- VITD_100484
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 27 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raimundo FV, Faulhaber GA, Menegatti PK, Marques Lda S, Furlanetto TW. Effect of High- versus Low-Fat Meal on Serum 25-Hydroxyvitamin D Levels after a Single Oral Dose of Vitamin D: A Single-Blind, Parallel, Randomized Trial. Int J Endocrinol. 2011;2011:809069. doi: 10.1155/2011/809069. Epub 2011 Dec 7.
PubMed 22190928Avnur Z, Nathan I, Dvilansky A, Livne A. Plasma constituent (s) inhibiting platelet adhesiveness. Isr J Med Sci. 1977 Mar;13(3):264-71.
PubMed 15956
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fat on Vitamin D Absorption After a Single Oral Dose
- ClinicalTrials.gov ID
- NCT01519986
- Acronym / sponsor ID
- VITD_100484 / VITD_100484
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Cholecalciferol, Supplementation, Dietary Supplements, Dietary Fats, 25-hydroxyvitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Jan 2012 (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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low fat Meal | Experimental | Dietary Supplement: Vitamin D3, Dietary Supplement: Placebo50,000 UI vitamin D3 with low fat meal |
| Medium fat meal | Experimental | Dietary Supplement: Vitamin D3, Dietary Supplement: Placebo50,000 UI vitamin D3 with medium fat meal |
| High fat meal | Experimental | Dietary Supplement: Vitamin D3, Dietary Supplement: Placebo50,000 UI vitamin D3 with high fat meal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| Vitamin D3Supplement of vitamin D3 | Dietary supplement | High fat meal, Low fat Meal, Medium fat meal |
| PlaceboPlacebo | Dietary supplement | High fat meal, Low fat Meal, Medium fat meal |
Primary outcome
Change from baseline in serum 25(OH)D at 14 day after intervention
Time frame: Change from baseline in serum 25(OH)D at 14 days
25(OH)D response to supplemental vitamin D3
1 secondary outcome
Change from baseline in Parathyroid hormone at 14 days after intervention
Time frame: Change from baseline in Parathyroid hormone at 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 27 Jan 2012.
- Background: PubMed 22190928Raimundo FV, Faulhaber GA, Menegatti PK, Marques Lda S, Furlanetto TW. Effect of High- versus Low-Fat Meal on Serum 25-Hydroxyvitamin D Levels after a Single Oral Dose of Vitamin D: A Single-Blind, Parallel, Randomized Trial. Int J Endocrinol. 2011;2011:809069. doi: 10.1155/2011/809069. Epub 2011 Dec 7.
- Background: PubMed 15956Avnur Z, Nathan I, Dvilansky A, Livne A. Plasma constituent (s) inhibiting platelet adhesiveness. Isr J Med Sci. 1977 Mar;13(3):264-71.
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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.
Tania W Furlanetto, PhD principal investigator
Federal University of Health Science of Porto Alegre
Gustavo AM Faulhaber, PhD study chair
Federal University of Health Science of Porto Alegre
Fabiana V Raimundo, MD study chair
Federal University of Health Science of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Vitamin D Deficiency, run by Federal University of Rio Grande do Sul.
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 27 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in serum 25(OH)D at 14 day after intervention (time frame: Change from baseline in serum 25(OH)D at 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01519986, which also lists 2 linked publications.
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 Jan 2012.