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

F

Federal University of Rio Grande do Sul

Status

Completed

Conditions

Deficiency, Vitamin D

Treatments

Dietary Supplement: colecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT00968734
GPPG_080606
FIPE, CAPES

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

Low fat meal
Experimental group
Treatment:
Dietary Supplement: colecalciferol
Hight fat meal
Experimental group
Treatment:
Dietary Supplement: colecalciferol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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