The Effect of Fat on Vitamin D Absorption

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

• Registration Number: NCT01519986
• Lead Sponsor: Federal University of Rio Grande do Sul

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

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-24
• Last Update Submitted: 2012-01-24
• Study First Posted: 2012-01-27
• Last Update Posted: 2012-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low fat Meal	Vitamin D3	50,000 UI vitamin D3 with low fat meal
Low fat Meal	Placebo	50,000 UI vitamin D3 with low fat meal
Medium fat meal	Vitamin D3	50,000 UI vitamin D3 with medium fat meal
Medium fat meal	Placebo	50,000 UI vitamin D3 with medium fat meal
High fat meal	Vitamin D3	50,000 UI vitamin D3 with high fat meal
High fat meal	Placebo	50,000 UI vitamin D3 with high fat meal

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum 25(OH)D at 14 day after intervention	Change from baseline in serum 25(OH)D at 14 days	25(OH)D response to supplemental vitamin D3

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Parathyroid hormone at 14 days after intervention	Change from baseline in Parathyroid hormone at 14 days	Parathyroid hormone response to supplemental vitamin D3