The Effect of Fat on Vitamin D Absorption (VITD_100484)

This study has been completed.
Sponsor:
Collaborators:
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Fabiana Viegas Raimundo, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01519986
First received: January 5, 2012
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: Vitamin D3
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of Fat on Vitamin D Absorption After a Single Oral Dose

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    25(OH)D response to supplemental vitamin D3


Secondary Outcome Measures:
  • Change from baseline in Parathyroid hormone at 14 days after intervention [ Time Frame: Change from baseline in Parathyroid hormone at 14 days ] [ Designated as safety issue: No ]
    Parathyroid hormone response to supplemental vitamin D3


Enrollment: 64
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low fat Meal
50,000 UI vitamin D3 with low fat meal
Dietary Supplement: Vitamin D3
Supplement of vitamin D3
Dietary Supplement: Placebo
Placebo
Experimental: Medium fat meal
50,000 UI vitamin D3 with medium fat meal
Dietary Supplement: Vitamin D3
Supplement of vitamin D3
Dietary Supplement: Placebo
Placebo
Experimental: High fat meal
50,000 UI vitamin D3 with high fat meal
Dietary Supplement: Vitamin D3
Supplement of vitamin D3
Dietary Supplement: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519986

Sponsors and Collaborators
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Tania W Furlanetto, PhD UFRGS
Study Chair: Gustavo AM Faulhaber, PhD UFRGS
Study Chair: Fabiana V Raimundo, MD UFRGS
  More Information

Publications:
Responsible Party: Fabiana Viegas Raimundo, Master Degree, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01519986     History of Changes
Other Study ID Numbers: VITD_100484
Study First Received: January 5, 2012
Last Updated: January 24, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
Vitamin D
Cholecalciferol
Supplementation
Dietary Supplements
Dietary Fats
25-hydroxyvitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014