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Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults

This study is ongoing, but not recruiting participants.
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 May 23, 2013