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| Sponsor: | Indiana University School of Health & Rehabilitation Sciences |
|---|---|
| Collaborators: |
USAID Global Livestock Collaborative Research Support Program Moi Univeristy University of California, Los Angeles Heifer Project International |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00562874 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Dietary Supplement: Meat Biscuit Dietary Supplement: Soy Biscuit Dietary Supplement: Wheat Biscuit |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment |
| Official Title: | Increasing Animal Source Foods in Diets of HIV-Infected Kenyan Women and Their Children |
| Estimated Enrollment: | 450 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Meat Biscuit: Experimental
75 women and one of their children will receive a biscuit containing dried meat as an ingredient for 5 days each week for 12 months.
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Dietary Supplement: Meat Biscuit
75 women and one of their children will receive a biscuit containing dried meat as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day.
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Soy Biscuit: Active Comparator
75 women and one of their children will receive a biscuit containing soy flour as an ingredient for 5 days each week for 12 months.
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Dietary Supplement: Soy Biscuit
75 women and one of their children will receive a biscuit containing soy four as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day.
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Wheat Biscuit: Sham Comparator
75 women and one of their children will receive a biscuit containing pm;u wheat flour as a source of protein as an ingredient for 5 days each week for 12 months.
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Dietary Supplement: Wheat Biscuit
75 women and one of their children will receive a biscuit containing only wheat lour as a source of protein as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 8 grams of protein per day and children will receive 350 calories and 5 grams of protein per day.
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Eligibility| Ages Eligible for Study: | 6 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Judith A Ernst, PhD | 317-274-9901 | jernst@iupui.edu |
| Contact: Grace K Ettyang, PhD | 254-0722-609257 | gaettyang@gmail.com |
| Kenya, Rift Valley Province | |
| Moi University-Academic Model for the Prevention and Treatment of HIV | Recruiting |
| Eldoret, Rift Valley Province, Kenya, 30100 | |
| Principal Investigator: Grace K Ettyang, PhD | |
| Sub-Investigator: Abraham Siika, MB ChB | |
| Sub-Investigator: Winstone Nyandiko, MB ChB | |
| Principal Investigator: Charlotte Neumann (UCLA), MD | |
| Principal Investigator: | Judith A Ernst, DMSc | Indiana University |
More Information
| Responsible Party: | Indiana University ( Judith A. Ernst ) |
| Study ID Numbers: | 0609-55, PCE-G-98-00036-00 |
| Study First Received: | November 21, 2007 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00562874 History of Changes |
| Health Authority: | United States: Institutional Review Board; Kenya: Institutional Review Board |
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HIV AIDS WOMEN KENYA |
NUTRITION HIV/AIDS treatment naive |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |