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

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ClinicalTrials.gov Identifier: NCT00562874
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : April 5, 2013
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Moi Univeristy
University of California, Los Angeles
Heifer Project International
USDA, Western Human Nutrition Research Center
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Health & Rehabilitation Sciences )

Tracking Information
First Submitted Date  ICMJE November 21, 2007
First Posted Date  ICMJE November 22, 2007
Last Update Posted Date April 5, 2013
Study Start Date  ICMJE June 2006
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2013)
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). [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
The impact of meat intake on mid-upper-arm muscle area (MAMA) will be assessed by comparisons, between groups, of the changes from baseline to 3, 6, 9 and 12 months; sample size is based on MAMA due to lower variability than CD4 lymphocyte count. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2013)
  • 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 [ Time Frame: 24 months ]
  • 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). [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
  • The impact of meat intake on immune function will be explored with actual measures of CD4 as well as percent of CD4 in the total lymphocyte; change in CD4 percent from baseline to 6 and 12 months will be compared between groups [ Time Frame: 12 months ]
  • The impact of meat intake on opportunistic infeection (OI) incidence will be assessed by measures of c-reactive protein and proportion of subjects with OI's; change over time will be compared between groups from baseline to 6 and 12 months. [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition Intervention in Drug Naive HIV-infected Kenyan Women and Their Children
Official Title  ICMJE Increasing Animal Source Foods in Diets of HIV-Infected Kenyan Women and Their Children
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: Meat Biscuit
  • Active Comparator: Soy Biscuit
    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.
    Intervention: Dietary Supplement: Soy Biscuit
  • Sham Comparator: Wheat Biscuit
    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.
    Intervention: Dietary Supplement: Wheat Biscuit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2013)
808
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2007)
450
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00562874
Other Study ID Numbers  ICMJE 0609-55
PCE-G-98-00036-00
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Indiana University ( Indiana University School of Health & Rehabilitation Sciences )
Study Sponsor  ICMJE Indiana University School of Health & Rehabilitation Sciences
Collaborators  ICMJE
  • United States Agency for International Development (USAID)
  • Moi Univeristy
  • University of California, Los Angeles
  • Heifer Project International
  • USDA, Western Human Nutrition Research Center
Investigators  ICMJE
Principal Investigator: Judith A Ernst, DMSc Indiana University
PRS Account Indiana University
Verification Date April 2013

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