The Effect of Fat on Vitamin D Absorption (VITD_100484)

January 24, 2012 updated by: Fabiana Viegas Raimundo, Federal University of Rio Grande do Sul

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low fat Meal
50,000 UI vitamin D3 with low fat meal
Dietary supplement: Placebo
Placebo
Dietary supplement: Vitamin D3
Supplement of vitamin D3
Experimental: Medium fat meal
50,000 UI vitamin D3 with medium fat meal
Dietary supplement: Placebo
Placebo
Dietary supplement: Vitamin D3
Supplement of vitamin D3
Experimental: High fat meal
50,000 UI vitamin D3 with high fat meal
Dietary supplement: Placebo
Placebo
Dietary supplement: Vitamin D3
Supplement of vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in serum 25(OH)D at 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Parathyroid hormone at 14 days after intervention
Time Frame: Change from baseline in Parathyroid hormone at 14 days
Parathyroid hormone response to supplemental vitamin D3
Change from baseline in Parathyroid hormone at 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Tania W Furlanetto, PhD, Federal University of Health Science of Porto Alegre
  • Study Chair: Gustavo AM Faulhaber, PhD, Federal University of Health Science of Porto Alegre
  • Study Chair: Fabiana V Raimundo, MD, Federal University of Health Science of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 27, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITD_100484

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe