Botswana Vitamin D Supplementation Study in HIV/AIDS

July 14, 2014 updated by: Virginia Stallings, Children's Hospital of Philadelphia
The goal is to determine the vit D supplementation dose that safely results in optimal serum vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Many people living with HIV/AIDS in African countries are vit D deficient or insufficient. Vit D deficiency in HIV/AIDS may be due to low dietary vit D intake, increased requirements, malabsorption, specific drug therapies (antiretrovirals, in particular), reduced outdoor physical activity, reduced vit D synthesis from UV light exposure in dark skin pigmented individuals, or unknown HIV-associated factors. Vit D deficiency likely contributes to abnormal immune status and increased inflammatory state, and to poor growth, bone, and muscle function, and may contribute to risk for tuberculosis (TB) infection. The goal is to determine the vit D supplementation dose that safely results in optimal serum 25D concentrations in HIV-infected children and adults living in Botswana.

To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
      • Gaborone, Botswana, 0000
        • Princess Marina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 51 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV infection
  • Ages 5.0 to 50.9 y
  • In usual state of good health
  • Subject and/or family commitment to the 12-week study

Exclusion Criteria:

  • Other chronic health conditions unrelated to HIV/AIDS that may affect nutritional status
  • Use of vit D supplementation above 400 IU/d

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 4000 IU/d of D3 by mouth for 12 weeks
Dietary supplement: 4000 IU/d D3 over 12 weeks
Experimental: 7000IU/d of D3 by mouth for 12 weeks
Dietary supplement: 7000 IU/d D3 over 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To test the efficacy of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to replete vit D status (achieving a minimum serum 25D concentration of 32 ng/mL).
Time Frame: 12 weeks
To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL.
12 weeks
To test the safety of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS as determined by serum calcium.
Time Frame: 12 weeks
To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess safety as determined by serum calcium.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 812323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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