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Sponsors and Collaborators: |
Academy for Educational Development Kenya Medical Research Institute |
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Information provided by: | Academy for Educational Development |
ClinicalTrials.gov Identifier: | NCT00838292 |
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 | Intervention |
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HIV Malnutrition HIV Infections |
Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate) Other: nutrition counseling |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 1049 |
Study Start Date: | August 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ART: food: Active Comparator
ART + food supplementation + nutrition counseling
|
Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
300 grams/day for 6 months
Other: nutrition counseling
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ART: no food: Active Comparator
ART + nutrition counseling
|
Other: nutrition counseling |
pre-ART: food: Active Comparator
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: nutrition counseling
|
pre-ART: no food: Active Comparator
no ART (cotrimoxazole provided) + nutrition counseling
|
Other: nutrition counseling |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Kenya | |
Nyeri Provincial Hospital | |
Nyeri, Kenya | |
Maragwa District Hospital | |
Maragwa, Kenya | |
Mbagathi District Hospital | |
Nairobi, Kenya | |
Naivasha District Hospital | |
Naivasha, Kenya | |
Mathere North Hospital | |
Nairobi, Kenya | |
Riruta City Council Hospital | |
Nairobi, Kenya |
Principal Investigator: | James Muttunga, Ph.D. | Kenya Medical Research Institute |
Principal Investigator: | Robert Mwadime, Ph.D. | Academy for Educational Development, FANTA Project |
Responsible Party: | Academy for Educational Development, FANTA Project ( Robert Mwadime and Tony Castleman ) |
Study ID Numbers: | AED 1 |
Study First Received: | February 3, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00838292 History of Changes |
Health Authority: | Kenya: Kenya Medical Research Institute; Kenya: Ethical Review Committee |
food supplementation HIV malnutrition |
Virus Diseases Sexually Transmitted Diseases, Viral Malnutrition HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Nutrition Disorders Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases Malnutrition HIV Infections Sexually Transmitted Diseases Lentivirus Infections Nutrition Disorders Retroviridae Infections |