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Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University College Cork.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University College Cork
ClinicalTrials.gov Identifier:
NCT01398202
First received: July 18, 2011
Last updated: July 19, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College Cork:

Primary Outcome Measures:
  • serum 25-hydroxyvitamin D concentration [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum parathyroid hormone [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • biochemical markers of bone turnover [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • serum calcium adjusted for albumin [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398202

Locations
Ireland
University College Cork
Cork, Ireland
Sponsors and Collaborators
University College Cork
Investigators
Principal Investigator: Kevin D Cashman, PhD University College Cork
  More Information

No publications provided by University College Cork

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Kevin Cashman, University College Cork
ClinicalTrials.gov Identifier: NCT01398202     History of Changes
Other Study ID Numbers: 111
Study First Received: July 18, 2011
Last Updated: July 19, 2011
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Cork:
Vitamin D status
25-hydroxyvitamin D
Vitamin D3
RCT
Bio-efficacy

Additional relevant MeSH terms:
Calcifediol
Cholecalciferol
Vitamin D
Ergocalciferols
Hydroxycholecalciferols
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013