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Randomized controlled trial comparing the impact of supplementary feeding with either ready-to-use therapeutic food or corn-soy blend among malnourished anti-retroviral therapy clients in Malawi

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67515515
Enrollment
450
Registered
2006-05-12
Start date
2006-01-06
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition and HIV infection Infections and Infestations HIV and malnutrition

Interventions

375 g CSB (300 g corn and 75 g soy flour fortified with vitamins and minerals), or 260 g peanut-based RUTF (26% dried skimmed milk, 27% sugar, 26% peanut paste, 20% vegetable oil, and 1.5% vitamins) a

Sponsors

St. Louis Children's Hospital (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults (>18 years old) diagnosed with acquired immune deficiency syndrome (AIDS) and meeting eligibility criteria for ART according to the National HIV treatment guidelines 2. World Health Organisation (WHO) stage III or IV or any WHO stage and a CD4 count <200 /mm^3 and beginning treatment with ART with a body mass index (BMI) of <18.5

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Pregnant or lactating women 3. Enrolment in any other supplementary feeding program

Design outcomes

Primary

MeasureTime frame
Body mass index and fat free body mass as measured by the bioelectrical impedance at 3, 6, 9 and 12 months

Secondary

MeasureTime frame
1. The number and severity of clinical events at 3, 6, 9 and 12 months 2. Monthly change in quality of life assessment 3. The change from baseline in the CD4 count at three months 4. Serum albumin and hematocrit at three months 5. Viral load at three months 6. Compliance with ART regimen 7. Cost-effectiveness of the two dietary regimens

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026