Study of Impacts of Food Supplementation on Malnourished HIV-Infected Adults in Kenya

This study has been completed.
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by:
Academy for Educational Development
ClinicalTrials.gov Identifier:
NCT00838292
First received: February 3, 2009
Last updated: March 12, 2009
Last verified: February 2009

February 3, 2009
March 12, 2009
August 2006
June 2008   (final data collection date for primary outcome measure)
Body Mass Index [ Time Frame: monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00838292 on ClinicalTrials.gov Archive Site
  • CD4 counts [ Time Frame: every three months (quarterly) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • drug adherence [ Time Frame: monthly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • HIV
  • Malnutrition
  • HIV Infections
  • Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
    300 grams/day for 6 months
    Other Name: Insta Products Ltd. Foundation Plus product with whey protein concentrate.
  • Other: nutrition counseling
  • Active Comparator: ART: food
    ART + food supplementation + nutrition counseling
    Interventions:
    • Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
    • Other: nutrition counseling
  • Active Comparator: ART: no food
    ART + nutrition counseling
    Intervention: Other: nutrition counseling
  • Active Comparator: pre-ART: food
    no ART (cotrimoxazole provided) + food supplementation + nutrition counseling
    Interventions:
    • Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
    • Other: nutrition counseling
  • Active Comparator: pre-ART: no food
    no ART (cotrimoxazole provided) + nutrition counseling
    Intervention: Other: nutrition counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1049
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00838292
AED 1
No
Robert Mwadime and Tony Castleman, Academy for Educational Development, FANTA Project
Academy for Educational Development
Kenya Medical Research Institute
Principal Investigator: James Muttunga, Ph.D. Kenya Medical Research Institute
Principal Investigator: Robert Mwadime, Ph.D. Academy for Educational Development, FANTA Project
Academy for Educational Development
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP