Trial | NCT00838292  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    whey protein ...

  • Study Participants

    1049
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.
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 Started
Aug 31
2006
Primary Completion
Jun 30
2008
Study Completion
Jun 30
2008
Last Update
Mar 13
2009
Estimate

Dietary Supplement fortified blended flour - Insta Foundation Plus (with whey protein concentrate)

300 grams/day for 6 months

  • Other names: Insta Products Ltd. Foundation Plus product with whey protein concentrate.

Other nutrition counseling

ART: food Active Comparator

ART + food supplementation + nutrition counseling

ART: no food Active Comparator

ART + nutrition counseling

pre-ART: food Active Comparator

no ART (cotrimoxazole provided) + food supplementation + nutrition counseling

pre-ART: no food Active Comparator

no ART (cotrimoxazole provided) + nutrition counseling

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
No Results Posted