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

July 18, 2011
July 20, 2011
December 2, 2015
January 2011
July 2011   (Final data collection date for primary outcome measure)
serum 25-hydroxyvitamin D concentration [ Time Frame: 10 weeks ]
Same as current
Complete list of historical versions of study NCT01398202 on Archive Site
  • serum parathyroid hormone [ Time Frame: 10 weeks ]
  • blood pressure [ Time Frame: 10 weeks ]
  • biochemical markers of bone turnover [ Time Frame: 10 weeks ]
  • serum calcium adjusted for albumin [ Time Frame: 10 weeks ]
Same as current
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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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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. doi: 10.3945/ajcn.111.031427. Epub 2012 May 2.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
45 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Kevin D. Cashman, University College Cork
University College Cork
Not Provided
Principal Investigator: Kevin D Cashman, PhD University College Cork
University College Cork
November 2015

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