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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01398202
Enrollment
56
Registered
2011-07-20
Start date
2011-01-31
Completion date
2011-09-30
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D

Keywords

Vitamin D status, 25-hydroxyvitamin D, Vitamin D3, RCT, Bio-efficacy

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTvitamin D3

20 micrograms per day for 10 weeks

DIETARY_SUPPLEMENT25-hydroxyvitamin D3

7 microgram/day for 10 weeks

DIETARY_SUPPLEMENT25-hydroxyvitamin D (20 microgram/day)

20 microgramday for 10 weeks

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

University College Cork
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
serum 25-hydroxyvitamin D concentration10 weeks

Secondary

MeasureTime frame
serum parathyroid hormone10 weeks
blood pressure10 weeks
biochemical markers of bone turnover10 weeks
serum calcium adjusted for albumin10 weeks

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026