Clinical trial NCT00838292: Study of Impacts of Food Supplementation on Malnourished HIV-Infected Adults in Kenya
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Malnutrition
HIV Infections
Keywords: food supplementation
HIV
malnutrition
Lead sponsor: Academy for Educational Development
Sponsor class: INDUSTRY
Collaborators: name: Kenya Medical Research Institute
First posted: 2009-02-06
Enrollment: 1049
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to test whether food supplementation of malnourished HIV-infected adults (both pre-ART and ART) in resource constrained settings improves their nutritional status, clinical status, effectiveness of treatment, quality of life, functioning, and survival.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index
timeFrame: monthly
Secondary outcomes:
measure: CD4 counts
timeFrame: every three months (quarterly)
measure: Quality of Life
timeFrame: monthly
measure: drug adherence
timeFrame: monthly
Other outcomes:
Locations:
city: Maragwa
country: Kenya
facility: Maragwa District Hospital
city: Nairobi
country: Kenya
facility: Mathere North Hospital
city: Nairobi
country: Kenya
facility: Mbagathi District Hospital
city: Nairobi
country: Kenya
facility: Riruta City Council Hospital
city: Naivasha
country: Kenya
facility: Naivasha District Hospital
city: Nyeri
country: Kenya
facility: Nyeri Provincial Hospital
Study officials:
affiliation: Kenya Medical Research Institute
name: James Muttunga, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Academy for Educational Development, FANTA Project
name: Robert Mwadime, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: