Vitamin D DeficiencyVitD-CaNCT01990872
Inter-relationship Between Vitamin D Requirements and Calcium Intake in Older Adults
A study testing Vitamin D3 (20 micrograms/day) in people with Vitamin D Deficiency, run by University College Cork at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3 (20 micrograms/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting white men and women aged ≥ 50 y
Who cannot join
- 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,
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- Known intestinal malabsorption syndrome,
- Excessive alcohol use,
- Taking medications known to interfere with vitamin D metabolism
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork, Cork, Ireland
Cork
About this study
Official title: Randomized Controlled Trial to Explore the Inter-relationship Between Vitamin D Requirements and Calcium Intake
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.
Read the detailed description
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
- Vitamin D Deficiency
- Being tested
- Vitamin D3 (20 micrograms/day), Placebo
- Keywords
- Vitamin D status, 25-hydroxyvitamin D, Vitamin D3, RCT, Calcium intake, Dietary requirement
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (20 micrograms/day)Dietary supplement
Vitamin D3 (20 micrograms/day)
PlaceboDietary supplement
Placebo (0 micrograms vitamin D3/day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo in high calcium group | Placebo comparator | Placebo + habitual dietary calcium intake (>1000 mg/d) Receives: Dietary Supplement: Placebo |
| Vitamin D3 in low/moderate calcium group | Active comparator | Vitamin D3 (20 microgram/day) + habitual calcium intake <700 mg/d Receives: Dietary Supplement: Vitamin D3 (20 micrograms/day) |
| Placebo in low/moderate calcium group | Placebo comparator | Placebo + habitual calcium intake <700 mg/d Receives: Dietary Supplement: Placebo |
| Vitamin D3 in high calcium group | Active comparator | Vitamin D3 (20 microgram/day) + habitual calcium intake (>1000 mg/d) Receives: Dietary Supplement: Vitamin D3 (20 micrograms/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of serum 25(OH)D concentration over winter in subjects stratified by calcium intake
Measured: 0, 8, 15 weeks
Secondary outcomes (6)
Serum albumin-adjusted calcium
Measured: 0, 8, 15 weeks
serum parathyroid hormone
Measured: 0, 8, 15 weeks
Serum 24,25(OH)2D
Measured: 0 and 15 weeks
Serum 1,25(OH)2D
Measured: 0 and 15 weeks
Serum free 25(OH)D
Measured: 0 and 15 weeks
Serum vitamin D binding protein
Measured: 0 and 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin D. Cashman, University College Cork
- Investigators
- Kevin D Cashman, BSc. PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990872
- Sponsor's protocol ID
- PR-IC-1111-10005
- Acronym
- VitD-Ca
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24828024Cashman 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.
PubMed 24695896
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Explore the Inter-relationship Between Vitamin D Requirements and Calcium Intake
- ClinicalTrials.gov ID
- NCT01990872
- Acronym / sponsor ID
- VitD-Ca / PR-IC-1111-10005
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D status, 25-hydroxyvitamin D, Vitamin D3, RCT, Calcium intake, Dietary requirement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo in high calcium group | Placebo comparator | Dietary Supplement: PlaceboPlacebo + habitual dietary calcium intake (>1000 mg/d) |
| Vitamin D3 in low/moderate calcium group | Active comparator | Dietary Supplement: Vitamin D3 (20 micrograms/day)Vitamin D3 (20 microgram/day) + habitual calcium intake <700 mg/d |
| Placebo in low/moderate calcium group | Placebo comparator | Dietary Supplement: PlaceboPlacebo + habitual calcium intake <700 mg/d |
| Vitamin D3 in high calcium group | Active comparator | Dietary Supplement: Vitamin D3 (20 micrograms/day)Vitamin D3 (20 microgram/day) + habitual calcium intake (>1000 mg/d) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting white men and women aged ≥ 50 y
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (20 micrograms/day)Vitamin D3 (20 micrograms/day) | Dietary supplement | Vitamin D3 in high calcium group, Vitamin D3 in low/moderate calcium group |
| PlaceboPlacebo (0 micrograms vitamin D3/day) | Dietary supplement | Placebo in high calcium group, Placebo in low/moderate calcium group |
Primary outcome
Response of serum 25(OH)D concentration over winter in subjects stratified by calcium intake
Time frame: 0, 8, 15 weeks
6 secondary outcomes
Serum albumin-adjusted calcium
Time frame: 0, 8, 15 weeks
serum parathyroid hormone
Time frame: 0, 8, 15 weeks
Serum 24,25(OH)2D
Time frame: 0 and 15 weeks
Serum 1,25(OH)2D
Time frame: 0 and 15 weeks
Serum free 25(OH)D
Time frame: 0 and 15 weeks
Serum vitamin D binding protein
Time frame: 0 and 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 24828024Cashman 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.
- Derived from this study: PubMed 24695896Cashman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin D Cashman, BSc. PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (20 micrograms/day) in people with Vitamin D Deficiency, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of serum 25(OH)D concentration over winter in subjects stratified by calcium intake (time frame: 0, 8, 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990872, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.