Vitamin D and HIV-Cardiovascular Disease in Children and... | NCT01410305

Studies
Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults

NCT01410305

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

Jun 28, 2016Estimated

Enrollment

290Actual

Phase

Not provided

Conditions

Vitamin D Deficiency

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Aug 4, 2011

First Submission Date that Met QC Criteria

Aug 4, 2011

First Posted Date

Aug 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2016

Last Update Posted Date

Jun 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Grace McComsey, Professor of Pediatrics and Medicine, University Hospitals Cleveland Medical CenterPrincipal Investigator

Lead Sponsor

University Hospitals Cleveland Medical CenterOTHER

Collaborators

Name	Class
Emory-Children's Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

290Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIV+		HIV Positive children or young people between the ages of 8 and 25
HIV Negative		HIV Negative matched controls by age and race

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	One time point at entry

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria - Documentation of HIV Infection Between ages of 8 and 25

On stable ART for at least 12 weeks for the HIV+ patients
Cumulative duration of ART for at least 48 weeks for HIV + patients
Healthy child/young adult with age and race matched to HIV+ patient for the HIV- controls
Absence of HIV based on medical and medication history

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grace McComsey, MD	University Hospitals Cleveland Medical Center	Principal Investigator
Allison Ross Eckard, MD	Emory-Children's Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory Chldren's Center		Atlanta	Georgia	30308	United States
University Hospitals Case Medical Center, Case Western Reserve University

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided