- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00838292
Study of Impacts of Food Supplementation on Malnourished HIV-Infected Adults in Kenya
Randomized Controlled Evaluation of the Impact of Food Supplements on Malnourished HIV-Infected Adult ART Clients and Malnourished, HIV-Infected Pre-ART Adults in Kenya
Study Overview
Status
Conditions
Detailed Description
Malnutrition remains a significant problem among HIV-infected populations, even among those with access to ART. In patients with HIV infection, poor nutritional status is associated with significant reduction in survival rates, accelerated disease progression, diminished response to therapies including ART, increased susceptibility to opportunistic infections, and reduced work capacity and quality of life. However, there is not evidence whether delay or reversal of weight loss improves life expectancy, nor is there evidence about the specific benefits food supplementation has on people with HIV infection. As antiretroviral therapy (ART) services continue to scale up in sub-Saharan Africa, there is a critical need for information about the impacts of appropriate food supplementation on the effectiveness of ART, on the health status of clients, and on the progression of the disease.
Malnourished adult ART and pre-ART clients at six clinical sites in Kenya are randomly allocated either to a group that receives nutrition counseling only or a group that receives nutrition counseling and supplementary feeding for six months. All patients continue to receive medical treatment (ART and other medicine) according to their condition. Baseline measures of socioeconomic and demographic status are collected. Measures of both nutritional and non-nutritional clinical outcomes are collected at baseline, 3, 6, 9, and 12 months. Clients beginning ART are treated as one arm and randomized between food and non-food, and clients not yet eligible for ART (pre-ART) are treated as a second arm and randomized between food and non-food. Within each arm, outcomes of subjects receiving supplemental food will be compared with outcomes of those who are not.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Maragwa, Kenya
- Maragwa District Hospital
-
Nairobi, Kenya
- Mbagathi District Hospital
-
Nairobi, Kenya
- Mathere North Hospital
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Nairobi, Kenya
- Riruta City Council Hospital
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Naivasha, Kenya
- Naivasha District Hospital
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Nyeri, Kenya
- Nyeri Provincial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV-infected
- BMI < 18.5
- Resident of area for past 6 months
Exclusion Criteria:
- Pregnant or lactating (child < 6 months)
- BMI > 18.5, BMI < 14
- Already receiving other food supplements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ART: food
ART + food supplementation + nutrition counseling
|
300 grams/day for 6 months
Other Names:
|
Active Comparator: ART: no food
ART + nutrition counseling
|
|
Active Comparator: pre-ART: food
no ART (cotrimoxazole provided) + food supplementation + nutrition counseling
|
300 grams/day for 6 months
Other Names:
|
Active Comparator: pre-ART: no food
no ART (cotrimoxazole provided) + nutrition counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Mass Index
Time Frame: monthly
|
monthly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD4 counts
Time Frame: every three months (quarterly)
|
every three months (quarterly)
|
Quality of Life
Time Frame: monthly
|
monthly
|
drug adherence
Time Frame: monthly
|
monthly
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James Muttunga, Ph.D., Kenya Medical Research Institute
- Principal Investigator: Robert Mwadime, Ph.D., Academy for Educational Development, FANTA Project
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AED 1
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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