Vitamin D DeficiencyNCT01410305
Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults
An observational study of Vitamin D Deficiency, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial summary
The relationship of Vitamin D levels in children and young adults to atherosclerosis. Read more about this study
- Who is it for?
- Ages 8 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 290 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Dec 2014
- Phase
- Observational
- 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 8 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.
Who may be able to join
None listed.
Who cannot join
- Taking > 800 IU of Vitamin D per day
- Parathyroid or Calcium disorders
- Acute illness and active inflammatory condition
- Chronic illnesses that include malignancy, diabetes, CAD
- Pregnancy and lactation
- Creatinine Clearance <50 ml/min
- Hgb < 9.0 g/dL
- AST and ALT > 2.5 upper limits of normal
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Chldren's Center
Atlanta, Georgia, 30308
University Hospitals Case Medical Center, Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults
The relationship of Vitamin D levels in children and young adults to atherosclerosis.
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Deficiency, HIV+ Children, HIV+ Young Adults
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ | HIV Positive children or young people between the ages of 8 and 25 | |
| HIV Negative | HIV Negative matched controls by age and race |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D levels
To perform a cross-sectional analysis of blood vitamin D status among the HIV-infected children and young adults to evaluated the point prevalence fo plasma 25(OH)D levels indicating vitamin D insufficiency, deficiency and severe deficiency, and to compare the prevalence to a matched uninfected healthy control group.
Measured: One time point at entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Emory-Children's Center
- Responsible party
- Principal investigator, Grace McComsey, University Hospitals Cleveland Medical Center
- Investigators
- Grace McComsey, MD, Principal investigator, University Hospitals Cleveland Medical CenterAllison Ross Eckard, MD, Principal investigator, Emory-Children's Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410305
- Sponsor's protocol ID
- 1R01HD070490-01
- Status last verified
- Jun 2016
- First submitted
- 4 Aug 2011
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults
- ClinicalTrials.gov ID
- NCT01410305
- Acronym / sponsor ID
- 1R01HD070490-01
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Deficiency, HIV+ Children, HIV+ Young Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Emory-Children's Center
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Aug 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 relationship of Vitamin D levels in children and young adults to atherosclerosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV+ | – | –HIV Positive children or young people between the ages of 8 and 25 |
| HIV Negative | – | –HIV Negative matched controls by age and race |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Taking > 800 IU of Vitamin D per day
- Parathyroid or Calcium disorders
- Acute illness and active inflammatory condition
- Chronic illnesses that include malignancy, diabetes, CAD
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin D levels
Time frame: One time point at entry
To perform a cross-sectional analysis of blood vitamin D status among the HIV-infected children and young adults to evaluated the point prevalence fo plasma 25(OH)D levels indicating vitamin D insufficiency, deficiency and severe deficiency, and to compare the prevalence to a matched uninfected healthy control group.
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 28 Jun 2016.
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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.
Grace McComsey, MD principal investigator
University Hospitals Cleveland Medical Center
Allison Ross Eckard, MD principal investigator
Emory-Children's Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by University Hospitals Cleveland Medical Center at 2 sites 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 0 inclusion and 8 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 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Vitamin D levels (time frame: One time point at entry). 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 28 Jun 2016.