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Completed

NCT Number: NCT01398202

Dietary Supplementation With 25-hydroxyvitamin D3 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.

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Key information

Conditions

Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Cork

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

20 micrograms per day for 10 weeks

25-hydroxyvitamin D3

Dietary Supplement

7 microgram/day for 10 weeks

25-hydroxyvitamin D (20 microgram/day)

Dietary Supplement

20 microgramday for 10 weeks

Placebo

Dietary Supplement

0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks

Primary outcomes

  1. serum 25-hydroxyvitamin D concentration

    Time frame: 10 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2011
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.