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

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ClinicalTrials.gov Identifier: NCT00838292
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : March 13, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
HIV Malnutrition HIV Infections 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1049 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : August 2006
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: monthly ]

Secondary Outcome Measures :
  1. CD4 counts [ Time Frame: every three months (quarterly) ]
  2. Quality of Life [ Time Frame: monthly ]
  3. drug adherence [ Time Frame: monthly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838292


Locations
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, Kenya
Sponsors and Collaborators
Academy for Educational Development
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
More Information

Responsible Party: Robert Mwadime and Tony Castleman, Academy for Educational Development, FANTA Project
ClinicalTrials.gov Identifier: NCT00838292     History of Changes
Other Study ID Numbers: AED 1
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: February 2009

Keywords provided by Academy for Educational Development:
food supplementation
HIV
malnutrition

Additional relevant MeSH terms:
HIV Infections
Malnutrition
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nutrition Disorders