Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults
Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week supplementation study during winter months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
1 active site
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
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 2, 2015
November 1, 2015
6 months
July 18, 2011
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum 25-hydroxyvitamin D concentration
10 weeks
Secondary Outcomes (4)
serum parathyroid hormone
10 weeks
blood pressure
10 weeks
biochemical markers of bone turnover
10 weeks
serum calcium adjusted for albumin
10 weeks
Study Arms (4)
Vitamin D3 (20 microgram/day)
ACTIVE COMPARATOR25-hydroxyvitamin D (7 microgram/day)
ACTIVE COMPARATOR25-hydroxyvitamin D3 (20 micogram/day)
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
7 microgram/day for 10 weeks
20 microgramday for 10 weeks
Eligibility Criteria
You may qualify if:
- Subjects will be eligible if they are 45+ years of age
- Body Mass Index (BMI) 19-30
You may not qualify if:
- have hypercalcaemia
- chronic illness
- renal or liver disorders
- taking medications that might interact with vitamin D or metabolite
- drank more than \> 21 standards (male)/ 14 standards (female) of alcohol per week
- planning to change smoking habits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College Cork
Cork, Ireland
Related Publications (1)
Cashman KD, Seamans KM, Lucey AJ, Stocklin E, Weber P, Kiely M, Hill TR. Relative effectiveness of oral 25-hydroxyvitamin D3 and vitamin D3 in raising wintertime serum 25-hydroxyvitamin D in older adults. Am J Clin Nutr. 2012 Jun;95(6):1350-6. doi: 10.3945/ajcn.111.031427. Epub 2012 May 2.
PMID: 22552038DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin D Cashman, PhD
University College Cork
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Food and Health
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 20, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2011
Study Completion
September 1, 2011
Last Updated
December 2, 2015
Record last verified: 2015-11