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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Malnutrition; HIV
• Intervention / Treatment: Dietary supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate); Other: nutrition counseling

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: Interventional
• Enrollment (Actual): 1049
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Maragwa, Kenya
    • Maragwa District Hospital
  • Nairobi, Kenya
    • Mbagathi District Hospital
  • Nairobi, Kenya
    • Mathere North Hospital
  • Nairobi, Kenya
    • Riruta City Council Hospital
  • Naivasha, Kenya
    • Naivasha District Hospital
  • Nyeri, Kenya
    • Nyeri Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ART: food; ART + food supplementation + nutrition counseling	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
Active Comparator: ART: no food; ART + nutrition counseling	Other: nutrition counseling
Active Comparator: pre-ART: food; no ART (cotrimoxazole provided) + food supplementation + nutrition counseling	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
Active Comparator: pre-ART: no food; no ART (cotrimoxazole provided) + nutrition counseling	Other: nutrition counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body Mass Index	monthly

Secondary Outcome Measures

Outcome Measure	Time Frame
CD4 counts	every three months (quarterly)
Quality of Life	monthly
drug adherence	monthly

Collaborators and Investigators

• Sponsor: Academy for Educational Development
• Collaborators: Kenya Medical Research Institute
• 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: August 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (Estimate): February 6, 2009

Study Record Updates

• Last Update Posted (Estimate): March 13, 2009
• Last Update Submitted That Met QC Criteria: March 12, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: HIV; malnutrition; food supplementation
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AED 1