NCT00968734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 5, 2010

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

August 28, 2009

Last Update Submit

March 4, 2010

Conditions

Deficiency, Vitamin D

Keywords

Vitamin Dcolecalciferolabsorption by Vitamin D

Outcome Measures

Primary Outcomes (1)

  • Serum Level of Vitamin D3

    14 days

Study Arms (2)

Low fat meal

EXPERIMENTAL
Dietary Supplement: colecalciferol

Hight fat meal

EXPERIMENTAL
Dietary Supplement: colecalciferol

Interventions

colecalciferolDIETARY_SUPPLEMENT

50.000UI single oral dose

Hight fat mealLow fat meal

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Residents of the hospital clinics of Porto Alegre

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Fabiana Viegas Raimundo, graduation

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Tania Weber Furlanetto, PhD

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 5, 2010

Record last verified: 2009-08

Locations

BR(1)