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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deficiency, Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low fat meal

Group Type EXPERIMENTAL

colecalciferol

Intervention Type DIETARY_SUPPLEMENT

50.000UI single oral dose

Hight fat meal

Group Type EXPERIMENTAL

colecalciferol

Intervention Type DIETARY_SUPPLEMENT

50.000UI single oral dose

Interventions

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colecalciferol

50.000UI single oral dose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No