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

Primary Purpose

Deficiency, Vitamin D

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
colecalciferol
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deficiency, Vitamin D focused on measuring Vitamin D, colecalciferol, absorption by Vitamin D

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low fat meal

Hight fat meal

Arm Description

Outcomes

Primary Outcome Measures

Serum Level of Vitamin D3

Secondary Outcome Measures

Full Information

First Posted
August 28, 2009
Last Updated
March 4, 2010
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT00968734
Brief Title
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
Acronym
VITDAB_08606
Official Title
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deficiency, Vitamin D
Keywords
Vitamin D, colecalciferol, absorption by Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low fat meal
Arm Type
Experimental
Arm Title
Hight fat meal
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
colecalciferol
Intervention Description
50.000UI single oral dose
Primary Outcome Measure Information:
Title
Serum Level of Vitamin D3
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabiana Viegas Raimundo, graduation
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tania Weber Furlanetto, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gustavo Faulhaber, Master
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosana Scalco, Master
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonardo Marques, Graduation
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paula Menegatti, Graduation
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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