HIV InfectionsPhase 2/3NCT01523496

Vitamin D Supplementation in HIV Youth

A Phase 2/3 study testing Vitamin D supplementation- in people with HIV Infections, run by University Hospitals Cleveland Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications. Read more about this study

Who is it for?: Ages 8 to 25 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Vitamin D supplementation-
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 190 participants
Where: 2 sitesUnited States
Study dates: Dec 2011to Aug 2016
Phase: Phase 2/3
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 8 to 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Ages 8-25
Documented HIV-1 infection
On stable antiretroviral therapy for > 3 months
Cumulative antiretroviral therapy of at least 6 months
25(OH)D level < 30 ng/ml at screening

Who cannot join

> 400 IU daily regular vitamin D intake
Parathyroid/calcium disorders
Active malignancy
Pregnancy/intent to become pregnant/breastfeeding
Chronic infectious/inflammatory conditions
Creatinine clearance < 50 ml/min

Show all 11Show fewer

Hemoglobin < 9.0 g/dL
Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal
Diabetes requiring hypoglycemic agents
Known coronary artery disease
Inability to swallow pills

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Emory Children's Center
Atlanta, Georgia, 30322
University Hospitals Case Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Vitamin D Supplementation and HIV-related Complications in Children and Young Adults

The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.

Read the detailed description

The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.

Conditions: HIV Infections
Being tested: Vitamin D control dose, Vitamin D supplementation-
Keywords: HIV, Vitamin D Deficiency
Medical subject headings: HIV Infections, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D control doseDrug
Also called 25(OH)D3 low dose
18,000 IU per month
Vitamin D supplementation-Drug
Also called 25(OH)D3 medium dose or 25(OH)high dose
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)

Study groups in NCT01523496
Study group	Role	What they receive
HIV + Young Adults	Active comparator	All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose) Receives: Drug: Vitamin D control dose; Drug: Vitamin D supplementation-
HIV - Controls	Active comparator	HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose) Receives: Drug: Vitamin D control dose; Drug: Vitamin D supplementation-

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Serum 25(OH)D3 Levels
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )
Measured: 6 months

Secondary outcomes (1)

Changes in Vitamin D Binding Protein (VDBP)
Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Aug 2016

First posted1 Feb 2012 (estimated)
Study startDec 2011
Primary completionAug 2016
Study completionAug 2016

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 (3)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01523496
Sponsor's protocol ID: 09-11-06
Status last verified: Feb 2018
First submitted: 27 Jan 2012
Last updated: 8 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Eckard AR, O'Riordan MA, Rosebush JC, Lee ST, Habib JG, Ruff JH, Labbato D, Daniels JE, Uribe-Leitz M, Tangpricha V, Chahroudi A, McComsey GA. Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth. Antivir Ther. 2018;23(4):315-324. doi: 10.3851/IMP3199.
PubMed 28994661
Eckard AR, Rosebush JC, O'Riordan MA, Graves CC, Alexander A, Grover AK, Lee ST, Habib JG, Ruff JH, Chahroudi A, McComsey GA. Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation. Antivir Ther. 2017;22(8):669-680. doi: 10.3851/IMP3157.
PubMed 28327462
Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016 May;11(3):277-84. doi: 10.1097/COH.0000000000000272.
PubMed 26890209

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin D Supplementation and HIV-related Complications in Children and Young Adults
ClinicalTrials.gov ID: NCT01523496
Acronym / sponsor ID: 09-11-06
Conditions: HIV Infections
Keywords: HIV, Vitamin D Deficiency
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: Emory University
Study start: Dec 2011
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 1 Feb 2012 (estimated)
Results: Posted 6 Feb 2018

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 determine the correct dose of Vitamin D to give to prevent HIV related complications.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HIV + Young Adults	Active comparator	Drug: Vitamin D control dose, Drug: Vitamin D supplementation-All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
HIV - Controls	Active comparator	Drug: Vitamin D control dose, Drug: Vitamin D supplementation-HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)

Who may qualify

Ages: 8 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Ages 8-25
Documented HIV-1 infection
On stable antiretroviral therapy for > 3 months
Cumulative antiretroviral therapy of at least 6 months
25(OH)D level < 30 ng/ml at screening

Key exclusion criteria (11 listed)

> 400 IU daily regular vitamin D intake
Parathyroid/calcium disorders
Active malignancy
Pregnancy/intent to become pregnant/breastfeeding
Chronic infectious/inflammatory conditions

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 D control doseAlso: 25(OH)D3 low dose18,000 IU per month	Drug	HIV + Young Adults, HIV - Controls
Vitamin D supplementation-Also: 25(OH)D3 medium dose or 25(OH)high dose60,000 IU per month(medium dose) or 120,000 IU/month(high dose)	Drug	HIV + Young Adults, HIV - Controls

Primary outcome

Changes in Serum 25(OH)D3 Levels
Time frame: 6 months
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )

1 secondary outcome

Changes in Vitamin D Binding Protein (VDBP)
Time frame: 6 months

Results and safety

Results posted to the registry on 6 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV+ With Vit D Supplementation	66	56
HIV+ Young Adults With Vitamin D Control Dose	36	32
HIV - With Vitamin D Supplementation	58	46
HIV - With Vitamin D Control Dose	30	27

Primary outcome: Changes in Serum 25(OH)D3 Levels

Time frame: 6 months. Median (Inter-Quartile Range). Unit: ng/mL

Measure	HIV Positive on Vit D Control Dose n = 32	HIV Positive on Vit D Supplementation Dose n = 56	HIV Negative on Vitamin D Control Dose n = 27	HIV Negative on Vitamin D Supplementation Dose n = 46
Value	11 (6 to 20)	22 (14 to 32)	7.5 (4 to 13)	25 (15 to 35)

Population analysed: HIV-infected on vitamin D control or supplementation dose and matched HIV-uninfected group on control or supplementation dose

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the study duration, at baseline, 6 months, and 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV + on Vitamin D Control Dose	0 of 36 (0%)	0 of 36 (0%)	0 of 36
HIV+ on Vitamin D Supplementation Dose	0 of 66 (0%)	0 of 66 (0%)	0 of 66
HIV - on Vitamin D Control Dose	0 of 30 (0%)	0 of 30 (0%)	0 of 58
HIV- on Vitamin D Supplementation Dose	0 of 58 (0%)	0 of 58 (0%)	0 of 30

Limitations and caveats (from the sponsor): Limitations to this study include the lack of adherence measures to study drug such as pill counts and the small sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28994661Eckard AR, O'Riordan MA, Rosebush JC, Lee ST, Habib JG, Ruff JH, Labbato D, Daniels JE, Uribe-Leitz M, Tangpricha V, Chahroudi A, McComsey GA. Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth. Antivir Ther. 2018;23(4):315-324. doi: 10.3851/IMP3199.
Derived from this study: PubMed 28327462Eckard AR, Rosebush JC, O'Riordan MA, Graves CC, Alexander A, Grover AK, Lee ST, Habib JG, Ruff JH, Chahroudi A, McComsey GA. Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation. Antivir Ther. 2017;22(8):669-680. doi: 10.3851/IMP3157.
Derived from this study: PubMed 26890209Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016 May;11(3):277-84. doi: 10.1097/COH.0000000000000272.

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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, FIDSA principal investigator

University Hospitals Cleveland Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vitamin D supplementation- in people with HIV Infections, 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 5 inclusion and 11 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 8 Mar 2018. 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.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 6 Feb 2018). 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?

Changes in Serum 25(OH)D3 Levels (time frame: 6 months). 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 NCT01523496, which also lists 3 linked publications.

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 8 Mar 2018.