Effect of High-Dose Vitamin D3 in Smokers and Non-Smokers With and Without HIV

NCT ID: NCT03270709

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2018-10-15

Brief Summary

Supplementation with vitamin D improves HIV+ macrophages phagocytosis in vitro. There is evidence to suggest that administering vitamin D can in fact improve immune function in individuals. The study will evaluate the impact of high dose vitamin D in HIV+ smokers' and HIV- smokers' in vivo. The primary goal is to improve innate immune host response to infection in patients already at high risk by virtue of HIV and smoking status.

Detailed Description

Tobacco smoke suppresses the lung's ability to fight infection. Smoking is three times more prevalent in the HIV+ compared to HIV- patients. Viral load was found to be significantly increased in HIV+ smokers compared to HIV+ non-smokers, suggesting that smoking enhances HIV-1 viral replication in macrophages, which contributes to disease progression. Vitamin D deficiency has been associated with increased mortality in HIV+ persons, but there is limited research on how this is impacting the health of these highest risk patients and if aggressive repletion with vitamin D can improve overall health.The study team hypothesizes that vitamin D administration will increase pathogen clearance and improve innate immune function.

The proposed pre and post interventional study is designed to characterize alveolar macrophage function and lung immunity according to tobacco use and HIV status, and determine the impact of high dose oral vitamin D3 on AM phagocytic function and innate immunity.

Conditions

HIV/AIDS; Vitamin D Deficiency; Smoker Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIV+ smokers

Vitamin D3 450,000 IU orally

Group Type: EXPERIMENTAL

Vitamin D3 450,000 IU orally

Intervention Type: DRUG

Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.

HIV- non-smokers

Vitamin D3 450,000 IU orally

Group Type: ACTIVE_COMPARATOR

Vitamin D3 450,000 IU orally

Intervention Type: DRUG

Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.

HIV+ non-smokers

Vitamin D3 450,000 IU orally

Group Type: ACTIVE_COMPARATOR

Vitamin D3 450,000 IU orally

Intervention Type: DRUG

Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.

HIV- smokers

Vitamin D3 450,000 IU orally

Group Type: ACTIVE_COMPARATOR

Vitamin D3 450,000 IU orally

Intervention Type: DRUG

Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.

Interventions

Vitamin D3 450,000 IU orally

Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects living with HIV-1 infection who have been on anti-retroviral therapy (ART) for a minimum of 12 months and are followed longitudinally for their HIV healthcare;
• Ability to give informed consent.

Exclusion Criteria

• Age <18 yrs old;
• Known or possible pregnancy or breastfeeding;
• Documented history of cirrhosis or a direct bilirubin ≥ 2.0 mg/dL;
• Documentation of left ventricular ejection fraction < 40% or myocardial infarction within the past 6 months;
• End-stage renal disease requiring dialysis or a serum creatinine ≥ 2 mg/d;
• Spirometry with forced vital capacity (FVC) or forced expiratory volume (FEV1)< 70% of predicted value;
• Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year;
• Inability to undergo bronchoscopy safely;
• High risk behaviors without known HIV status.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Jenny Elizabeth Han

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny E Han, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Atlanta VA Medical center

Atlanta, Georgia, United States

Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00094833

Identifier Type: -

Identifier Source: org_study_id