The Effect of Fat on Vitamin D Absorption

NCT ID: NCT01519986

Last Updated: 2012-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low fat Meal

50,000 UI vitamin D3 with low fat meal

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Supplement of vitamin D3

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Medium fat meal

50,000 UI vitamin D3 with medium fat meal

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Supplement of vitamin D3

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

High fat meal

50,000 UI vitamin D3 with high fat meal

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Supplement of vitamin D3

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Vitamin D3

Supplement of vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Residents of the hospital clinics of Porto Alegre

Exclusion Criteria

* Don't drink milk
* Obesity
* Malnutrition
* Liver disease
* Kidney disease or diabetes
* Use of dietary supplements containing calcium and vitamin D
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Fabiana Viegas Raimundo

Master Degree

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tania W Furlanetto, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Gustavo AM Faulhaber, PhD

Role: STUDY_CHAIR

Federal University of Health Science of Porto Alegre

Fabiana V Raimundo, MD

Role: STUDY_CHAIR

Federal University of Health Science of Porto Alegre

References

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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.

Reference Type BACKGROUND
PMID: 22190928 (View on PubMed)

Avnur Z, Nathan I, Dvilansky A, Livne A. Plasma constituent (s) inhibiting platelet adhesiveness. Isr J Med Sci. 1977 Mar;13(3):264-71.

Reference Type BACKGROUND
PMID: 15956 (View on PubMed)

Other Identifiers

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VITD_100484

Identifier Type: -

Identifier Source: org_study_id

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