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Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398202
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Kevin D. Cashman, University College Cork

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.

Condition or disease Intervention/treatment Phase
Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D Dietary Supplement: vitamin D3 Dietary Supplement: 25-hydroxyvitamin D3 Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day) Dietary Supplement: Placebo Not Applicable

Detailed Description:
The UK (McCance & Widdowson) food composition tables suggests that 25-hydroxyvitamin D (which is present in some foods, albeit at very low concentrations, but which is also commercially available) may possess up to 5-times the activity of native vitamin D3 in food. Thus, in theory, each micogram of 25-hydroxyvitamin D consumed in the diet could boost vitamin D status up to five times most effectively compared to each microgram of native vitamin D in food. It is worth noting, however, that estimates of potency range from 2 to 5, depending on approach used, and that the real potency needs to be confirmed in a human study. This study aims to examine the biological activity of 25-hydroxyvitamin D (i.e., its potency relative to vitamin D3) as well as its effect on selected functional markers in a randomised, double-blind, human intervention trial in older adults.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults
Study Start Date : January 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Vitamin D3 (20 microgram/day) Dietary Supplement: vitamin D3
20 micrograms per day for 10 weeks

Active Comparator: 25-hydroxyvitamin D (7 microgram/day) Dietary Supplement: 25-hydroxyvitamin D3
7 microgram/day for 10 weeks

Active Comparator: 25-hydroxyvitamin D3 (20 micogram/day) Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day)
20 microgramday for 10 weeks

Placebo Comparator: Placebo Dietary Supplement: Placebo
0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks

Primary Outcome Measures :
  1. serum 25-hydroxyvitamin D concentration [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. serum parathyroid hormone [ Time Frame: 10 weeks ]
  2. blood pressure [ Time Frame: 10 weeks ]
  3. biochemical markers of bone turnover [ Time Frame: 10 weeks ]
  4. serum calcium adjusted for albumin [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects will be eligible if they are 45+ years of age
  • Body Mass Index (BMI) 19-30

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398202

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University College Cork
Cork, Ireland
Sponsors and Collaborators
University College Cork
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Principal Investigator: Kevin D Cashman, PhD University College Cork
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kevin D. Cashman, Professor of Food and Health, University College Cork Identifier: NCT01398202    
Other Study ID Numbers: 111
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Kevin D. Cashman, University College Cork:
Vitamin D status
25-hydroxyvitamin D
Vitamin D3
Additional relevant MeSH terms:
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Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents