The Effect of Fat on Vitamin D Absorption

Vitamin D Deficiency Clinical Trial

— VITD_100484  

Official title:

The Effect of Fat on Vitamin D Absorption After a Single Oral Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519986
• Other study ID #: VITD_100484
• Status: Completed
• Phase: N/A
• First received: January 5, 2012
• Last updated: January 24, 2012
• Start date: September 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 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: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Supplement of vitamin D3
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Hospital de Clinicas de Porto Alegre

References & Publications (2)

Avnur Z, Nathan I, Dvilansky A, Livne A. Plasma constituent (s) inhibiting platelet adhesiveness. Isr J Med Sci. 1977 Mar;13(3):264-71. — View Citation

Raimundo FV, Faulhaber GA, Menegatti PK, Marques Lda S, Furlanetto TW. Effect of High- versus Low-Fat Meal on Serum 25-Hydroxyvitamin D Levels after a Single Oral Dose of Vitamin D: A Single-Blind, Parallel, Randomized Trial. Int J Endocrinol. 2011;2011:809069. doi: 10.1155/2011/809069. Epub 2011 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum 25(OH)D at 14 day after intervention	25(OH)D response to supplemental vitamin D3	Change from baseline in serum 25(OH)D at 14 days	No
Secondary	Change from baseline in Parathyroid hormone at 14 days after intervention	Parathyroid hormone response to supplemental vitamin D3	Change from baseline in Parathyroid hormone at 14 days	No