The Effect of Fat on Vitamin D Absorption
VITD_100484
1 other identifier
interventional
64
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 27, 2012
CompletedJanuary 27, 2012
January 1, 2012
1 month
January 5, 2012
January 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change from baseline in Parathyroid hormone at 14 days after intervention
Change from baseline in Parathyroid hormone at 14 days
Study Arms (3)
Low fat Meal
EXPERIMENTAL50,000 UI vitamin D3 with low fat meal
Medium fat meal
EXPERIMENTAL50,000 UI vitamin D3 with medium fat meal
High fat meal
EXPERIMENTAL50,000 UI vitamin D3 with high fat meal
Interventions
Eligibility Criteria
You may qualify if:
- Residents of the hospital clinics of Porto Alegre
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 22190928BACKGROUNDAvnur Z, Nathan I, Dvilansky A, Livne A. Plasma constituent (s) inhibiting platelet adhesiveness. Isr J Med Sci. 1977 Mar;13(3):264-71.
PMID: 15956BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tania W Furlanetto, PhD
Federal University of Health Science of Porto Alegre
- STUDY CHAIR
Gustavo AM Faulhaber, PhD
Federal University of Health Science of Porto Alegre
- STUDY CHAIR
Fabiana V Raimundo, MD
Federal University of Health Science of Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master Degree
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 27, 2012
Study Start
September 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
January 27, 2012
Record last verified: 2012-01