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NCT01990872

Inter-relationship Between Vitamin D Requirements and Calcium Intake in Older Adults

NCT ID: NCT01990872

Last Updated: 2013-11-25

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

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

Brief Summary

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This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial (RCT) aims to examine the impact of various levels of habitual calcium intake on dietary vitamin D requirements in older adults stratified by calcium intake. This will provide new data on the impact of different levels of calcium intake, ranging from low/moderate to high, on winter serum 25(OH)D levels, and their utilization and catabolism in adults.

Detailed Description

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The aim of this study is to perform a randomised controlled vitamin D3 intervention study in apparently healthy, free-living adults (aged 50+ y) to investigate whether different levels of habitual calcium intake, ranging from low-moderate to high, influence serum 25(OH)D concentrations and indices of vitamin D activation and catabolism during winter, when vitamin D intake is adequate versus inadequate.

This research will provide new data and scientific understanding in relation to the impact of different levels of dietary calcium intake on vitamin D requirements in the older adult population. As such, this new data will inform dietary reference values for vitamin D.

Conditions

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Vitamin D Deficiency

Keywords

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Vitamin D status 25-hydroxyvitamin D Vitamin D3 RCT Calcium intake Dietary requirement

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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Placebo in high calcium group

Placebo + habitual dietary calcium intake (\>1000 mg/d)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (0 micrograms vitamin D3/day)

Vitamin D3 in low/moderate calcium group

Vitamin D3 (20 microgram/day) + habitual calcium intake \<700 mg/d

Group Type ACTIVE_COMPARATOR

Vitamin D3 (20 micrograms/day)

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (20 micrograms/day)

Placebo in low/moderate calcium group

Placebo + habitual calcium intake \<700 mg/d

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (0 micrograms vitamin D3/day)

Vitamin D3 in high calcium group

Vitamin D3 (20 microgram/day) + habitual calcium intake (\>1000 mg/d)

Group Type ACTIVE_COMPARATOR

Vitamin D3 (20 micrograms/day)

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (20 micrograms/day)

Interventions

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Vitamin D3 (20 micrograms/day)

Vitamin D3 (20 micrograms/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (0 micrograms vitamin D3/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Consenting white men and women aged ≥ 50 y

Exclusion Criteria

* Unwilling to discontinue consumption of vitamin D-containing supplements 4 wks before the initiation of the study and throughout the study.
* Planning to take a winter vacation (during the course of the 15-wk intervention) to a location at which either the altitude or the latitude was predicted to result in significant cutaneous vitamin D synthesis from solar radiation (e.g., a winter sun coastal resort or a mountain ski resort)
* Use of tanning facilities of any type.
* Pregnancy or planning to become pregnant during the study
* A severe medical illness,
* hypercalcaemia,
* Known intestinal malabsorption syndrome,
* Excessive alcohol use,
* Taking medications known to interfere with vitamin D metabolism

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 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, BSc. PhD

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Locations

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Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork, Cork, Ireland

Cork, , Ireland

Site Status

Countries

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Ireland

References

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Cashman KD, Kinsella M, Walton J, Flynn A, Hayes A, Lucey AJ, Seamans KM, Kiely M. The 3 epimer of 25-hydroxycholecalciferol is present in the circulation of the majority of adults in a nationally representative sample and has endogenous origins. J Nutr. 2014 Jul;144(7):1050-7. doi: 10.3945/jn.114.192419. Epub 2014 May 14.

Reference Type DERIVED

PMID: 24828024 (View on PubMed)

Cashman KD, Hayes A, O'Donovan SM, Zhang JY, Kinsella M, Galvin K, Kiely M, Seamans KM. Dietary calcium does not interact with vitamin D(3) in terms of determining the response and catabolism of serum 25-hydroxyvitamin D during winter in older adults. Am J Clin Nutr. 2014 Jun;99(6):1414-23. doi: 10.3945/ajcn.113.080358. Epub 2014 Apr 2.

Reference Type DERIVED

PMID: 24695896 (View on PubMed)

Other Identifiers

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PR-IC-1111-10005

Identifier Type: -

Identifier Source: org_study_id