Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults

Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398202
• Other study ID #: 111
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: November 30, 2015
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2015
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D

Intervention

Dietary Supplement:
• vitamin D3
20 micrograms per day for 10 weeks
• 25-hydroxyvitamin D3
7 microgram/day for 10 weeks
• 25-hydroxyvitamin D (20 microgram/day)
20 microgramday for 10 weeks
• Placebo
0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks

Locations

Country	Name	City	State
Ireland	University College Cork	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxyvitamin D concentration		10 weeks	No
Secondary	serum parathyroid hormone		10 weeks	No
Secondary	blood pressure		10 weeks	No
Secondary	biochemical markers of bone turnover		10 weeks	No
Secondary	serum calcium adjusted for albumin		10 weeks	Yes