HealthyNCT01139840
Relative Efficacy of Vitamins D2 and D3 in Adult Humans
A study testing vitamin D2 and vitamin D3 in people with Healthy, run by Creighton University at 1 site in United States.
Trial summary
Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- vitamin D2 and vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2010
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willingness to withhold supplement use for duration of study
- willingness to avoid sun exposure for duration of study
Who cannot join
- vitamin D supplement use
- conditions that affect vitamin D metabolism by the body
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
Official title: Vitamin D Status: Relative Efficacy of Vitamins D2 and D3
Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.
- Conditions
- Healthy
- Being tested
- vitamin D2, vitamin D3
- Keywords
- vitamin D2, vitamin D3, ergocalciferol, cholecalciferol, vitamin D status, To determine relative potency of vitamins D2 and D3 under conditions of continuous administration, To determine change in vitamin D content of subcutaneous fat after 12 weeks' administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D2Dietary supplement
Study Supplement
vitamin D3Dietary supplement
Study Supplement
| Study group | Role | What they receive |
|---|---|---|
| vitamin D2 | Active comparator | Not described Receives: Dietary Supplement: vitamin D2 |
| vitamin D3 | Active comparator | Not described Receives: Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for increment in serum 25(OH)D
Measured: 12 weeks
Secondary outcomes (1)
change in vitamin D content of subcutaneous fat
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionSep 2010
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 HealthyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Future Foundation, BTR Group
- Responsible party
- Sponsor
- Investigators
- Robert P Heaney, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139840
- Sponsor's protocol ID
- 09-15612
- Status last verified
- Oct 2011
- First submitted
- 7 Jun 2010
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.
PubMed 21177785
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status: Relative Efficacy of Vitamins D2 and D3
- ClinicalTrials.gov ID
- NCT01139840
- Acronym / sponsor ID
- 09-15612
- Conditions
- Healthy
- Keywords
- vitamin D2, vitamin D3, ergocalciferol, cholecalciferol, vitamin D status, To determine relative potency of vitamins D2 and D3 under conditions of continuous administration, To determine change in vitamin D content of subcutaneous fat after 12 weeks' administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Health Future Foundation, BTR Group
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Jun 2010 (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.
Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D2 | Active comparator | Dietary Supplement: vitamin D2 |
| vitamin D3 | Active comparator | Dietary Supplement: vitamin D3 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willingness to withhold supplement use for duration of study
- willingness to avoid sun exposure for duration of study
Key exclusion criteria (2 listed)
- vitamin D supplement use
- conditions that affect vitamin D metabolism by the body
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 D2Study Supplement | Dietary supplement | vitamin D2 |
| vitamin D3Study Supplement | Dietary supplement | vitamin D3 |
Primary outcome
AUC for increment in serum 25(OH)D
Time frame: 12 weeks
1 secondary outcome
change in vitamin D content of subcutaneous fat
Time frame: 12 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 31 Oct 2011.
- Derived from this study: PubMed 21177785Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.
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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.
Robert P Heaney, MD principal investigator
Creighton University
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 D2 and vitamin D3 in people with Healthy, run by Creighton University at 1 site in United States.
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 2 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 31 Oct 2011. 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 United States. 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. 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?
AUC for increment in serum 25(OH)D (time frame: 12 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 NCT01139840, 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 31 Oct 2011.