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

This study has been completed.
Sponsor:
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00968734
First received: August 28, 2009
Last updated: March 4, 2010
Last verified: August 2009
History of Changes
  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
Deficiency, Vitamin D
 Dietary Supplement: colecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Serum Level of Vitamin D3 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low fat meal Dietary Supplement: colecalciferol
50.000UI single oral dose
Experimental: Hight fat meal Dietary Supplement: colecalciferol
50.000UI single oral dose

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968734

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Fabiana Viegas Raimundo, Universidade Federal do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT00968734     History of Changes
Other Study ID Numbers: FIPE, CAPES, GPPG_080606
Study First Received: August 28, 2009
Last Updated: March 4, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Rio Grande do Sul:
Vitamin D
colecalciferol
absorption by Vitamin D

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

ClinicalTrials.gov processed this record on May 19, 2013