HIVNCT00838292
Study of Impacts of Food Supplementation on Malnourished HIV-Infected Adults in Kenya
A study testing fortified blended flour - Insta Foundation Plus (with whey protein concentrate) and nutrition counseling in people with HIV and Malnutrition, run by Academy for Educational Development at 6 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Malnutrition, HIV Infections
- What is being tested?
- fortified blended flour - Insta Foundation Plus (with whey protein concentrate) and nutrition counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,049 participants
- Where
- 6 sitesKenya
- Study dates
- Aug 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected
- BMI < 18.5
- Resident of area for past 6 months
Who cannot join
- Pregnant or lactating (child < 6 months)
- BMI > 18.5, BMI < 14
- Already receiving other food supplements
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Kenya6 sites
Maragwa District Hospital
Maragwa
Mathere North Hospital
Nairobi
Mbagathi District Hospital
Nairobi
Riruta City Council Hospital
Nairobi
Naivasha District Hospital
Naivasha
Nyeri Provincial Hospital
Nyeri
About this 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
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.
Read the 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.
- Conditions
- HIV, Malnutrition, HIV Infections
- Being tested
- fortified blended flour - Insta Foundation Plus (with whey protein concentrate), nutrition counseling
- Keywords
- food supplementation, HIV, malnutrition
- Medical subject headings
- Malnutrition, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified blended flour - Insta Foundation Plus (with whey protein concentrate)Dietary supplement
Also called Insta Products Ltd. Foundation Plus product with whey protein concentrate.
300 grams/day for 6 months
nutrition counselingOther
| Study group | Role | What they receive |
|---|---|---|
| ART: food | Active comparator | ART + food supplementation + nutrition counseling Receives: Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate); Other: nutrition counseling |
| ART: no food | Active comparator | ART + nutrition counseling Receives: Other: nutrition counseling |
| pre-ART: food | Active comparator | no ART (cotrimoxazole provided) + food supplementation + nutrition counseling Receives: Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate); Other: nutrition counseling |
| pre-ART: no food | Active comparator | no ART (cotrimoxazole provided) + nutrition counseling Receives: Other: nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: monthly
Secondary outcomes (3)
CD4 counts
Measured: every three months (quarterly)
Quality of Life
Measured: monthly
drug adherence
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy for Educational Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kenya Medical Research Institute
- Investigators
- James Muttunga, Ph.D., Principal investigator, Kenya Medical Research InstituteRobert Mwadime, Ph.D., Principal investigator, Academy for Educational Development, FANTA Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838292
- Sponsor's protocol ID
- AED 1
- Status last verified
- Feb 2009
- First submitted
- 3 Feb 2009
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00838292
- Acronym / sponsor ID
- AED 1
- Conditions
- HIV, Malnutrition, HIV Infections
- Keywords
- food supplementation, HIV, malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,049 participants (actual)
- Lead sponsor
- Academy for Educational DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Kenya Medical Research Institute
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ART: food | Active comparator | Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate), Other: nutrition counselingART + food supplementation + nutrition counseling |
| ART: no food | Active comparator | Other: nutrition counselingART + nutrition counseling |
| pre-ART: food | Active comparator | Dietary Supplement: fortified blended flour - Insta Foundation Plus (with whey protein concentrate), Other: nutrition counselingno ART (cotrimoxazole provided) + food supplementation + nutrition counseling |
| pre-ART: no food | Active comparator | Other: nutrition counselingno ART (cotrimoxazole provided) + nutrition counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infected
- BMI < 18.5
- Resident of area for past 6 months
Key exclusion criteria (3 listed)
- Pregnant or lactating (child < 6 months)
- BMI > 18.5, BMI < 14
- Already receiving other food supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fortified blended flour - Insta Foundation Plus (with whey protein concentrate)Also: Insta Products Ltd. Foundation Plus product with whey protein concentrate.300 grams/day for 6 months | Dietary supplement | ART: food, pre-ART: food |
| nutrition counseling | Other | ART: food, ART: no food, pre-ART: food, pre-ART: no food |
Primary outcome
Body Mass Index
Time frame: monthly
3 secondary outcomes
CD4 counts
Time frame: every three months (quarterly)
Quality of Life
Time frame: monthly
drug adherence
Time frame: monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Muttunga, Ph.D. principal investigator
Kenya Medical Research Institute
Robert Mwadime, Ph.D. principal investigator
Academy for Educational Development, FANTA Project
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fortified blended flour - Insta Foundation Plus (with whey protein concentrate) and nutrition counseling in people with HIV and Malnutrition, run by Academy for Educational Development at 6 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2009; AzTrials last refreshed its copy on 8 Nov 2026.