Vitamin D Status as Reflected by Serum 25-hydroxyvitamin DNCT01398202
Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults
A study testing vitamin D3, 25-hydroxyvitamin D3 and 25-hydroxyvitamin D (20 microgram/day) in people with Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D
- What is being tested?
- vitamin D3, 25-hydroxyvitamin D3 and 25-hydroxyvitamin D (20 microgram/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2011to Sep 2011
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be eligible if they are 45+ years of age
- Body Mass Index (BMI) 19-30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults
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.
Read the 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.
- Being tested
- vitamin D3, 25-hydroxyvitamin D3, 25-hydroxyvitamin D (20 microgram/day), Placebo
- Keywords
- Vitamin D status, 25-hydroxyvitamin D, Vitamin D3, RCT, Bio-efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
20 micrograms per day for 10 weeks
25-hydroxyvitamin D3Dietary supplement
7 microgram/day for 10 weeks
25-hydroxyvitamin D (20 microgram/day)Dietary supplement
20 microgramday for 10 weeks
PlaceboDietary supplement
0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (20 microgram/day) | Active comparator | Not described Receives: Dietary Supplement: vitamin D3 |
| 25-hydroxyvitamin D (7 microgram/day) | Active comparator | Not described Receives: Dietary Supplement: 25-hydroxyvitamin D3 |
| 25-hydroxyvitamin D3 (20 micogram/day) | Active comparator | Not described Receives: Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxyvitamin D concentration
Measured: 10 weeks
Secondary outcomes (4)
serum parathyroid hormone
Measured: 10 weeks
blood pressure
Measured: 10 weeks
biochemical markers of bone turnover
Measured: 10 weeks
serum calcium adjusted for albumin
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D Status as Reflected by Serum 25-hydroxyvitamin DStudies 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
- 56 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, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398202
- Sponsor's protocol ID
- 111
- Status last verified
- Nov 2015
- First submitted
- 18 Jul 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22552038
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults
- ClinicalTrials.gov ID
- NCT01398202
- Acronym / sponsor ID
- 111
- Keywords
- Vitamin D status, 25-hydroxyvitamin D, Vitamin D3, RCT, Bio-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jul 2011 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (20 microgram/day) | Active comparator | Dietary Supplement: vitamin D3 |
| 25-hydroxyvitamin D (7 microgram/day) | Active comparator | Dietary Supplement: 25-hydroxyvitamin D3 |
| 25-hydroxyvitamin D3 (20 micogram/day) | Active comparator | Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects will be eligible if they are 45+ years of age
- Body Mass Index (BMI) 19-30
Key exclusion criteria (6 listed)
- 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
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 D320 micrograms per day for 10 weeks | Dietary supplement | Vitamin D3 (20 microgram/day) |
| 25-hydroxyvitamin D37 microgram/day for 10 weeks | Dietary supplement | 25-hydroxyvitamin D (7 microgram/day) |
| 25-hydroxyvitamin D (20 microgram/day)20 microgramday for 10 weeks | Dietary supplement | 25-hydroxyvitamin D3 (20 micogram/day) |
| Placebo0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks | Dietary supplement | Placebo |
Primary outcome
serum 25-hydroxyvitamin D concentration
Time frame: 10 weeks
4 secondary outcomes
serum parathyroid hormone
Time frame: 10 weeks
blood pressure
Time frame: 10 weeks
biochemical markers of bone turnover
Time frame: 10 weeks
serum calcium adjusted for albumin
Time frame: 10 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 2 Dec 2015.
- Derived from this study: PubMed 22552038Cashman 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.
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, 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, 25-hydroxyvitamin D3 and 25-hydroxyvitamin D (20 microgram/day) in people with Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D, 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 2 inclusion and 6 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 2 Dec 2015. 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?
serum 25-hydroxyvitamin D concentration (time frame: 10 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 NCT01398202, which also lists 1 linked publication.
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 2 Dec 2015.