Vitamin D DeficiencyNCT01633658
The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3
A study testing cholecalciferol and 25(OH)D in people with Vitamin D Deficiency, run by Creighton University at 1 site in United States.
Trial summary
The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol and 25(OH)D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ten men and women in each group,
- aged 20-60.
Who cannot join
- History of hypercalcemia,
- vitamin D supplement use > 800 IU daily,
- BMI > 30,
- gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
- use of steroids in any form,
- anticonvulsants,
Show all 9Show fewer
- antibiotics,
- acute illness, or
- vacation planned to "sunny climate"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study
The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
Read the detailed description
Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol, 25(OH)D
- Keywords
- vitamin D
- 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.
cholecalciferolDietary supplement
a single dose of 2500 micrograms of cholecalciferol
25(OH)DDietary supplement
a single dose of 625 micrograms of 25(OH)D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Cholecalciferol | Active comparator | A single dose of 2500 micrograms cholecalciferol Receives: Dietary Supplement: cholecalciferol |
| 25(OH)D | Experimental | A single dose of 625 micrograms 25(OH)D Receives: Dietary Supplement: 25(OH)D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D response
25(OH)D will be measured at frequent time intervals over 28 days.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Protocol has changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Armas, MD,MS, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633658
- Sponsor's protocol ID
- Creighton 13
- Status last verified
- May 2013
- First submitted
- 2 Jul 2012
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT01633658
- Acronym / sponsor ID
- Creighton 13
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol has changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 4 Jul 2012 (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 investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
Detailed description
Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Cholecalciferol | Active comparator | Dietary Supplement: cholecalciferolA single dose of 2500 micrograms cholecalciferol |
| 25(OH)D | Experimental | Dietary Supplement: 25(OH)DA single dose of 625 micrograms 25(OH)D |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ten men and women in each group,
- aged 20-60.
Key exclusion criteria (9 listed)
- History of hypercalcemia,
- vitamin D supplement use > 800 IU daily,
- BMI > 30,
- gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
- use of steroids in any form,
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 |
|---|---|---|
| cholecalciferola single dose of 2500 micrograms of cholecalciferol | Dietary supplement | Vitamin D Cholecalciferol |
| 25(OH)Da single dose of 625 micrograms of 25(OH)D | Dietary supplement | 25(OH)D |
Primary outcome
Serum 25(OH)D response
Time frame: 28 days
25(OH)D will be measured at frequent time intervals over 28 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Laura Armas, MD,MS 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 cholecalciferol and 25(OH)D in people with Vitamin D Deficiency, 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 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: withdrawn, as of the sponsor's last update on 29 May 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 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 was withdrawn before enrolling participants, so there are no results.
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(OH)D response (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2013.