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Completed

NCT Number: NCT01990872

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Vitamin D3 (20 micrograms/day)

Dietary Supplement

Vitamin D3 (20 micrograms/day)

Placebo

Dietary Supplement

Placebo (0 micrograms vitamin D3/day)

Primary outcomes

  1. Response of serum 25(OH)D concentration over winter in subjects stratified by calcium intake

    Time frame: 0, 8, 15 weeks

Secondary outcomes

  1. Serum albumin-adjusted calcium

    Time frame: 0, 8, 15 weeks

  2. serum parathyroid hormone

    Time frame: 0, 8, 15 weeks

  3. Serum 24,25(OH)2D

    Time frame: 0 and 15 weeks

  4. Serum 1,25(OH)2D

    Time frame: 0 and 15 weeks

  5. Serum free 25(OH)D

    Time frame: 0 and 15 weeks

  6. Serum vitamin D binding protein

    Time frame: 0 and 15 weeks

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

Randomized Controlled Trial to Explore the Inter-relationship Between Vitamin D Requirements and Calcium Intake

Acronym: VitD-Ca

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 25, 2013
Registry last updated
Nov 25, 2013

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.

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