Trial record 8 of 39 for:    " January 14, 2009":" February 13, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by:
Academy for Educational Development
ClinicalTrials.gov Identifier:
NCT00838292
First received: February 3, 2009
Last updated: March 12, 2009
Last verified: February 2009
  Purpose

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
HIV
Malnutrition
HIV Infections
Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
Other: nutrition counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Academy for Educational Development:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD4 counts [ Time Frame: every three months (quarterly) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • drug adherence [ Time Frame: monthly ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838292

Locations
Kenya
Maragwa District Hospital
Maragwa, Kenya
Riruta City Council Hospital
Nairobi, Kenya
Mbagathi District Hospital
Nairobi, Kenya
Mathere North 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

No publications provided

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
Study First Received: February 3, 2009
Last Updated: March 12, 2009
Health Authority: Kenya: Kenya Medical Research Institute
Kenya: Ethical Review Committee

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

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

ClinicalTrials.gov processed this record on July 31, 2014