The Pediatric HIV Nutrition Study in Uganda (NOURISH)
Child Nutrition Disorders
About this trial
This is an interventional supportive care trial for Child Nutrition Disorders
Eligibility Criteria
Inclusion Criteria:
- HIV-infected children aged 6 months to 12 years, including Well Nourished (WN), Moderately Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) patients initiating on ART within 2 weeks, whose carer is aged ≥18 years and has provided informed consent.
- Malnourished HIV-infected children aged 6 months to 12 years stabilized on ART for at least 6 months and initiating on RUTF, whose carer is aged ≥18 years and has provided informed consent.
Exclusion Criteria:
- Previous enrollment in a nutritional therapeutic program in the last 3 months
- Children involved in an on-going nutrition study
- Children who have previously received the tuberculin skin test (TST) or mantoux or purified protein derivative (PPD) in the last 3 months.
- Children with clinically suspected or confirmed malignancy
- Children exhibiting any specific food intolerance
- Children who are vomiting profusely (over 3 times daily)
- Children living outside 50 km radius from Infectious Diseases Institute at Mulago, Kampala
- Children whose carers do not want to disclose their home address.
- Children whose cause of malnutrition is compounded by congenital malformations, chromosomal disorders, metabolic disorders, congenital immune disorders, cerebral palsy
- Children with a severe disability limiting the possibility of investigations
- Children who plan to leave the catchment area in the next 6 months
Sites / Locations
- Infectious Diseases InstituteRecruiting
- Mildmay International Centre KampalaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Active Comparator
Active Comparator
Well-nourished HIV+ ART naive
Moderately-malnourished HIV+; RUTF
Severely acute-malnourished HIV+; RUTF
These children aged between 6months-12years will be followed up for 12weeks to look at their nutrition, immune and pharmacological responses. They will receive routine nutritional and ART adherence counseling
These children aged between 6months - 12years, ART naive or experienced, will be initiating ready-to-use-therapeutic(RUTF) food and will be followed up for 12 weeks to see the effect of nutrition supplementation on immune and pharmacological responses
These children aged between 6months - 12years, ART naive or experienced, will be initiating ready-to-use-therapeutic(RUTF) food and will be followed up for 12 weeks to see the effect of nutrition supplementation on immune and pharmacological responses