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Clinical Trials/ISRCTN04084517
ISRCTN04084517
Completed
Not Applicable

A randomised controlled study assessing the effect of nutritional intervention with ready to use therapeutic food (RUTF) on blood lipid profiles of moderate to severely malnourished adults receiving antiretroviral therapy (ART) in Lusaka, Zambia

Valid International (UK)0 sites168 target enrollmentMarch 24, 2009
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ConditionsHIV and malnutritionInfections and InfestationsHuman immunodeficiency virus [HIV] disease resulting in other specified diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV and malnutrition
Sponsor
Valid International (UK)
Enrollment
168
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 24, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Valid International (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Eligible for ART or has started ART within last 2 weeks
  • •2\. Both males and females, age \>\=18 years to \<\=49 years
  • •3\. mid\-upper arm circumference (MUAC) \<22\.0 cm
  • •4\. Body mass index (BMI) \<17\.0 kg/m^2
  • •5\. CD4 Count \>50
  • •6\. Signed informed consent

Exclusion Criteria

  • •1\. Pre\-existing diabetes
  • •2\. History of cardiovascular disease (CVD) including hypercholestrolaemia, hypertension
  • •3\. On other medications that may have an effect on blood lipid profiles (besides routine HIV prophylaxis and tuberculosis \[TB] treatment)
  • •4\. CD4 count \<50
  • •5\. Unable to tolerate solid foods
  • •6\. Failed appetite test
  • •7\. Subjects with pacemakers or any implantable electronic devices
  • •8\. Pregnancy or lactation
  • •9\. Psychiatric illness
  • •10\. Nut allergies

Outcomes

Primary Outcomes

Not specified

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