Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults

NCT ID: NCT01398202

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D3 (20 microgram/day)

Group Type ACTIVE_COMPARATOR

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

20 micrograms per day for 10 weeks

25-hydroxyvitamin D (7 microgram/day)

Group Type ACTIVE_COMPARATOR

25-hydroxyvitamin D3

Intervention Type DIETARY_SUPPLEMENT

7 microgram/day for 10 weeks

25-hydroxyvitamin D3 (20 micogram/day)

Group Type ACTIVE_COMPARATOR

25-hydroxyvitamin D (20 microgram/day)

Intervention Type DIETARY_SUPPLEMENT

20 microgramday for 10 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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vitamin D3

20 micrograms per day for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

25-hydroxyvitamin D3

7 microgram/day for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

25-hydroxyvitamin D (20 microgram/day)

20 microgramday for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Kevin D. Cashman

Professor of Food and Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin D Cashman, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Locations

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University College Cork

Cork, , Ireland

Site Status

Countries

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Ireland

References

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Cashman KD, Seamans KM, Lucey AJ, Stocklin 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.

Reference Type DERIVED
PMID: 22552038 (View on PubMed)

Other Identifiers

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111

Identifier Type: -

Identifier Source: org_study_id