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The Pediatric HIV Nutrition Study in Uganda (NOURISH)

Primary Purpose

Child Nutrition Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
RUTF
Sponsored by
Infectious Diseases Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Child Nutrition Disorders

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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:

  1. Previous enrollment in a nutritional therapeutic program in the last 3 months
  2. Children involved in an on-going nutrition study
  3. Children who have previously received the tuberculin skin test (TST) or mantoux or purified protein derivative (PPD) in the last 3 months.
  4. Children with clinically suspected or confirmed malignancy
  5. Children exhibiting any specific food intolerance
  6. Children who are vomiting profusely (over 3 times daily)
  7. Children living outside 50 km radius from Infectious Diseases Institute at Mulago, Kampala
  8. Children whose carers do not want to disclose their home address.
  9. Children whose cause of malnutrition is compounded by congenital malformations, chromosomal disorders, metabolic disorders, congenital immune disorders, cerebral palsy
  10. Children with a severe disability limiting the possibility of investigations
  11. 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

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Well-nourished HIV+ ART naive

Moderately-malnourished HIV+; RUTF

Severely acute-malnourished HIV+; RUTF

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in numbers of circulating immune cell population and their capacity to release cytokines
Immune response

Secondary Outcome Measures

Occurrence of Immune reconstitution inflammatory syndrome (IRIS)
Episodes of Opportunistic infections - Clinical outcomes
Occurrence of re-feeding syndrome
Episodes of Opportunistic infections - Clinical outcomes
Pharmacological: Cmax
Cmax of Non-nucleotide reverse - transcriptase inhibitors (NNRTI) and Protease Inhibitors(PIs) at 0weeks, 6weeks,12weeks
Pharmacological: AUC
Area Under Curve (AUC) Time Frame: 0weeks, 6weeks, 12weeks for nevirapine and lopinvir/retonavir
Number of participants with adverse events
Pharmacological: Number of participants with adverse events

Full Information

First Posted
February 18, 2015
Last Updated
April 15, 2015
Sponsor
Infectious Diseases Institute
Collaborators
University of Dublin, Trinity College
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1. Study Identification

Unique Protocol Identification Number
NCT02421302
Brief Title
The Pediatric HIV Nutrition Study in Uganda
Acronym
NOURISH
Official Title
The Role of Nutrition as a Determinant of Immune Function and Pharmacological Outcome Amongst HIV Infected Malnourished Children in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Infectious Diseases Institute
Collaborators
University of Dublin, Trinity College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be cohort study design with both qualitative and quantitative methods of data collection. The investigators are aiming to study 64 HIV positive children as healthy controls either initiating ART or already on ART and 86 malnourished HIV infected children on ART or naïve initiating ART and RUTF aged between 6 months to 12 years. Primary carers will be asked to provide informed consent whereby the children and primary carers will be enrolled into the study and followed up for 12 weeks.
Detailed Description
BACKGROUND: Malnutrition and Human Immunodeficiency Virus (HIV) infection are intimately linked and present a serious health challenge in Africa. Approximately 30-50% of children in Uganda with severe acute malnutrition (SAM) are HIV infected. Studies on nutrition as a determinant of immune response and drug metabolism in malnourished children are unknown. GAP: Clinicians have noted that certain patients deteriorate after starting ART and nutritional supplementation despite viralogical suppression and immunological improvement with a paradoxical emergence of certain opportunistic infections, electrolyte derangement and malnutrition hence IRIS or re-feeding syndrome (RF). There is paucity of data on nutrition as a determinant of immune and pharmacological response amongst HIV infected malnourished children despite malnutrition being common. HYPOTHESIS: Well-nourished HIV infected children ART naïve or experienced will have a better nutritional, clinical, immunological and pharmacological outcome than malnourished children ART naïve or experienced. METHODS: A cohort design studying 75 malnourished HIV infected children on ART and RUTF comparing them to 75 well-nourished children ART naive or experienced aged between 6 months to 12 years after primary carers have provided informed consent will be enrolled into the study and followed up for 12 weeks. IMPACT: This study will endeavor to provide appropriate information that will enhance the management of malnourished HIV infected children in the context of both ART and RUTF and their impact on immune response and drug metabolism. The study will also generate other research questions that need to be addressed in order to optimize HIV services amongst malnourished children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Nutrition Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Well-nourished HIV+ ART naive
Arm Type
No Intervention
Arm Description
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
Arm Title
Moderately-malnourished HIV+; RUTF
Arm Type
Active Comparator
Arm Description
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
Arm Title
Severely acute-malnourished HIV+; RUTF
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF
Other Intervention Name(s)
Ready-to-Use-Therapeutic-Food
Intervention Description
This is ready-to-use-therapeutic-food
Primary Outcome Measure Information:
Title
Changes in numbers of circulating immune cell population and their capacity to release cytokines
Description
Immune response
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Occurrence of Immune reconstitution inflammatory syndrome (IRIS)
Description
Episodes of Opportunistic infections - Clinical outcomes
Time Frame
12 weeks
Title
Occurrence of re-feeding syndrome
Description
Episodes of Opportunistic infections - Clinical outcomes
Time Frame
12 weeks
Title
Pharmacological: Cmax
Description
Cmax of Non-nucleotide reverse - transcriptase inhibitors (NNRTI) and Protease Inhibitors(PIs) at 0weeks, 6weeks,12weeks
Time Frame
12 weeks
Title
Pharmacological: AUC
Description
Area Under Curve (AUC) Time Frame: 0weeks, 6weeks, 12weeks for nevirapine and lopinvir/retonavir
Time Frame
12 weeks
Title
Number of participants with adverse events
Description
Pharmacological: Number of participants with adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Orikiiriza, MMED
Phone
+256312307000
Ext
224
Email
jorikiiriza@idi.co.ug
First Name & Middle Initial & Last Name or Official Title & Degree
Allen M Mukhwana, MBA
Phone
+256312307000
Ext
242
Email
amukhwana@idi.co.ug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Orikiiriza, MMED
Organizational Affiliation
PhD Candidate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Diseases Institute
City
Kampala
ZIP/Postal Code
256
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Lamorde, PhD
Phone
+256312307000
Ext
320
Email
mlamorde@idi.co.ug
First Name & Middle Initial & Last Name & Degree
Allen M Mukhwana, MBA
Phone
+256312307000
Ext
242
Email
amukhwana@idi.co.ug
First Name & Middle Initial & Last Name & Degree
Andrew Kambugu, MMED
Facility Name
Mildmay International Centre Kampala
City
Kampala
ZIP/Postal Code
256
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Orikiiriza, MMED
Phone
+256307000
Ext
244
Email
jorikiiza@idi.co.ug
First Name & Middle Initial & Last Name & Degree
Jane Nakaweesi, MMED
Phone
+256 312 210 200
Email
nakawesijane@gmail.com

12. IPD Sharing Statement

Learn more about this trial

The Pediatric HIV Nutrition Study in Uganda

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