Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal (VITDAB_08606)

March 4, 2010 updated by: Federal University of Rio Grande do Sul
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

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low fat meal
Dietary supplement: colecalciferol
50.000UI single oral dose
EXPERIMENTAL: Hight fat meal
Dietary supplement: colecalciferol
50.000UI single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Level of Vitamin D3
Time Frame: 14 days
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

Investigators

  • Principal Investigator: Fabiana Viegas Raimundo, graduation, Federal University of Rio Grande do Sul
  • Study Director: Tania Weber Furlanetto, PhD, Federal University of Rio Grande do Sul
  • Principal Investigator: Gustavo Faulhaber, Master, Federal University of Rio Grande do Sul
  • Principal Investigator: Rosana Scalco, Master, Hospital de Clínicas de Porto Alegre
  • Principal Investigator: Leonardo Marques, Graduation, Hospital de Clínicas de Porto Alegre
  • Principal Investigator: Paula Menegatti, Graduation, Hospital de Clínicas de Porto Alegre

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

August 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (ESTIMATE)

August 31, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2010

Last Update Submitted That Met QC Criteria

March 4, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIPE, CAPES
  • GPPG_080606

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.

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