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

Deficiency, Vitamin D Clinical Trial

— VITDAB_08606  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968734
• Other study ID #: FIPE, CAPES
• Secondary ID: GPPG_080606
• Status: Completed
• Phase: N/A
• First received: August 28, 2009
• Last updated: March 4, 2010
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2009
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deficiency, Vitamin D
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• colecalciferol
50.000UI single oral dose

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Level of Vitamin D3		14 days	Yes