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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838292
• Other study ID #: AED 1
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: March 12, 2009
• Start date: August 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: Academy for Educational Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Kenya Medical Research InstituteKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1049
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV
• HIV Infections
• Malnutrition

Intervention

Dietary Supplement:
• fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
300 grams/day for 6 months

Other:
• nutrition counseling

Locations

Country	Name	City	State
Kenya	Maragwa District Hospital	Maragwa
Kenya	Mathere North Hospital	Nairobi
Kenya	Mbagathi District Hospital	Nairobi
Kenya	Riruta City Council Hospital	Nairobi
Kenya	Naivasha District Hospital	Naivasha
Kenya	Nyeri Provincial Hospital	Nyeri

Sponsors (2)

Lead Sponsor	Collaborator
Academy for Educational Development	Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		monthly	No
Secondary	CD4 counts		every three months (quarterly)	No
Secondary	Quality of Life		monthly	No
Secondary	drug adherence		monthly	No