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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

July 18, 2011
July 19, 2011
January 2011
July 2011   (final data collection date for primary outcome measure)
serum 25-hydroxyvitamin D concentration [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01398202 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D
  • Dietary Supplement: vitamin D3
    20 micrograms per day for 10 weeks
  • Dietary Supplement: 25-hydroxyvitamin D3
    7 microgram/day for 10 weeks
  • Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day)
    20 microgramday for 10 weeks
  • Dietary Supplement: Placebo
    0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks
  • Active Comparator: Vitamin D3 (20 microgram/day)
    Intervention: Dietary Supplement: vitamin D3
  • Active Comparator: 25-hydroxyvitamin D (7 microgram/day)
    Intervention: Dietary Supplement: 25-hydroxyvitamin D3
  • Active Comparator: 25-hydroxyvitamin D3 (20 micogram/day)
    Intervention: Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day)
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Cashman KD, Seamans KM, Lucey AJ, Stöcklin 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. Epub 2012 May 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT01398202
111
Yes
Professor Kevin Cashman, University College Cork
University College Cork
Not Provided
Principal Investigator: Kevin D Cashman, PhD University College Cork
University College Cork
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP