Study of Impacts of Food Supplementation on Malnourished HIV-Infected Adults in Kenya
NCT ID: NCT00838292
Last Updated: 2009-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1049 participants
INTERVENTIONAL
2006-08-31
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nutritional Support for HIV-Tuberculosis Co-infected Adults in Senegal, West Africa
NCT03711721
Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
NCT03848728
Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda
NCT00122941
Multi-vitamins, HAART and HIV/AIDS in Uganda
NCT01228578
The Pediatric HIV Nutrition Study in Uganda
NCT02421302
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ART: food
ART + food supplementation + nutrition counseling
fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
300 grams/day for 6 months
nutrition counseling
ART: no food
ART + nutrition counseling
nutrition counseling
pre-ART: food
no ART (cotrimoxazole provided) + food supplementation + nutrition counseling
fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
300 grams/day for 6 months
nutrition counseling
pre-ART: no food
no ART (cotrimoxazole provided) + nutrition counseling
nutrition counseling
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fortified blended flour - Insta Foundation Plus (with whey protein concentrate)
300 grams/day for 6 months
nutrition counseling
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI \< 18.5
* Resident of area for past 6 months
Exclusion Criteria
* BMI \> 18.5, BMI \< 14
* Already receiving other food supplements
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kenya Medical Research Institute
OTHER
Academy for Educational Development
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Academy for Educational Development, FANTA Project
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Muttunga, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kenya Medical Research Institute
Robert Mwadime, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Academy for Educational Development, FANTA Project
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AED 1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.