Human Immunodeficiency Virus (HIV)Phase 2NCT01093417
Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
A Phase 2 study testing Vitamin D in people with Human Immunodeficiency Virus (HIV) and Vitamin D Deficiency, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Vitamin D Deficiency, HIV Infections
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior
- 25-hydroxyvitamin D level <20
- On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry
Who cannot join
- Pregnancy or Breast Feeding
- Diabetes
- Creatinine Clearance <50
- Any active infectious or inflammatory condition
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).
Read the detailed description
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Human Immunodeficiency Virus (HIV), Complementary Therapies
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Vitamin D Deficiency, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Calciferol
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
PlaceboOther
Placebo pills will be administered to enrollees in this arm
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants that have been randomized into this arm will receive placebo pills. Receives: Other: Placebo |
| Vitamin D 4000 IU | Active comparator | Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily. Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Function
Endothelial function measured by flow mediated brachial artery dilation
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change in Serum 25-hydroxyvitamin D Concentration in Both Groups
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace McComsey, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093417
- Sponsor's protocol ID
- 11-09-30
- Status last verified
- Jun 2016
- First submitted
- 24 Mar 2010
- Last updated
- 14 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Longenecker CT, Hileman CO, Carman TL, Ross AC, Seydafkan S, Brown TT, Labbato DE, Storer N, Tangpricha V, McComsey GA. Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial. Antivir Ther. 2012;17(4):613-21. doi: 10.3851/IMP1983. Epub 2011 Nov 17.
PubMed 22293363
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
- ClinicalTrials.gov ID
- NCT01093417
- Acronym / sponsor ID
- 11-09-30
- Keywords
- Vitamin D, Human Immunodeficiency Virus (HIV), Complementary Therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 29 Feb 2012
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 evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).
Detailed description
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants that have been randomized into this arm will receive placebo pills. |
| Vitamin D 4000 IU | Active comparator | Drug: Vitamin DParticipants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected
- HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior
- 25-hydroxyvitamin D level <20
- On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry
Key exclusion criteria (5 listed)
- Pregnancy or Breast Feeding
- Diabetes
- Creatinine Clearance <50
- Any active infectious or inflammatory condition
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months prior to study entry
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 DAlso: CalciferolVitamin D 4000 IU will be administered to enrollees on the active comparator arm | Drug | Vitamin D 4000 IU |
| PlaceboPlacebo pills will be administered to enrollees in this arm | Other | Placebo |
Primary outcome
Change in Endothelial Function
Time frame: Baseline and 12 weeks
Endothelial function measured by flow mediated brachial artery dilation
1 secondary outcome
Change in Serum 25-hydroxyvitamin D Concentration in Both Groups
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22293363Longenecker CT, Hileman CO, Carman TL, Ross AC, Seydafkan S, Brown TT, Labbato DE, Storer N, Tangpricha V, McComsey GA. Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial. Antivir Ther. 2012;17(4):613-21. doi: 10.3851/IMP1983. Epub 2011 Nov 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D in people with Human Immunodeficiency Virus (HIV) and Vitamin D Deficiency, run by University Hospitals Cleveland Medical Center 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 4 inclusion and 5 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 14 Jul 2016. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Endothelial Function (time frame: Baseline and 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 NCT01093417, 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 14 Jul 2016.