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Nutrition Intervention in Drug Naive HIV-infected Kenyan Women and Their Children

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Meat Biscuit (Dietary Supplement); Soy Biscuit (Dietary Supplement); Wheat Biscuit (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: Indiana University School of Health & Rehabilitation Sciences

Official(s) and/or principal investigator(s):
Judith A Ernst, DMSc, Principal Investigator, Affiliation: Indiana University

Summary

Many of the 28 million people with immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) estimated to be living in sub-Saharan Africa also suffer from malnutrition. Reproductive age women, their infants and young children are among the most vulnerable for malnutrition and progression of HIV to AIDS and mortality is increased in the malnourished, as seen in Eastern and Southern Africa. The HIV Nutrition Project (HNP) research evaluates the effect of protein and micronutrients in meat on the health and nutritional well being of Kenyan women living with HIV in rural Kenya and the health and development of their children, by means of a randomized nutrition intervention. We will determine if meat in the diets of HIV- infected women and their children (1) protects the immune system and prevents severe infection, (2) prevents the loss of body mass and enhances the quality of life among drug naïve women not yet ill enough to warrant antiretroviral drugs and (3) positively impacts growth and development of vulnerable children of the HIV-infected women when compared to those given supplements with the same amount of energy but with either soya or wheat protein. The intervention food with beef protein provides significant vitamin B12, lysine and bio-available iron, zinc and selenium when compared to the soya and wheat supplements. Deficiencies of these nutrients may hasten HIV disease progression. The findings from our project may have implications for the development of initiatives that are either sustainable or subsidized by the local, regional and/or global economies that ensure that all HIV-infected individuals have access to adequate nutrition support that includes foods that provide enough nutrients that are needed to optimize health and well-being. The knowledge gained may significantly impact other populations at high risk for decreased immune function such as those with tuberculosis and malaria. This is a 3 arm randomized design where 225 HIV-infected rural Kenyan mothers with a CD4 between 250 and 500, WHO Stage 1 or 2, and with no co-existing infections, receive with their child, a nutrition biscuit supplement daily (5 days/week) for 12 months. These women are not yet ill enough to warrant treatment with antiretroviral drugs in Kenya and therefore a food intervention may keep them healthy longer and delay the need for drugs.

Clinical Details

Official title: Increasing Animal Source Foods in Diets of HIV-Infected Kenyan Women and Their Children

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: The impact of meat intake on mid-upper-arm muscle area; comparisons between groups, of changes from baseline to 3, 6, 9, 12, 15, 18 mos (intervention); 24 mos (6 mos post intervention).

Secondary outcome:

The impact of meat intake on immune function (CD4 as well as percent of CD4 in the total lymphocyte); change from baseline to 6, 12, 18 mos (intervention), 24 months (6 mos post intervention)will be compared between groups

The impact of meat intake on opportunistic infection (OI) incidence will be assessed monthly; change over time will be compared between groups from baseline through 18 mos (intervention and at 24 mos (6 mos post intervention).

Eligibility

Minimum age: 6 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

HIV-infected women and their children who live in the Turbo catchment area in the Uasin Gishu District of Kenya and attend the AMPATH clinic there will be invited to participate in the study. Inclusion Criteria:

- Women will be included if drug naïve and classified as WHO Stage 1 or 2 54 with a CD4

count greater than 250.

- The youngest child in the household between 6 months and 10 years who has no evidence

of one or more OIs or illnesses will also be followed. Exclusion Criteria:

- Women will be excluded if the initial CD4 is less than or equal to 250, they suffer

from one or more OIs, are pregnant, or qualify as recipients of the AMPATH standard of care HHI, World Food Program or USAID Unimix food supplement interventions.

- Should the designated child be HIV positive with advanced disease and therefore not

meet inclusion criteria, the next oldest child less than 10 years who meets the study criteria will be the designated child.

Locations and Contacts

Moi University-Academic Model for the Prevention and Treatment of HIV, Eldoret, Rift Valley Province 30100, Kenya
Additional Information

Starting date: June 2006
Last updated: April 3, 2013

Page last updated: August 23, 2015

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