NCT02421302|Unknown
The Pediatric HIV Nutrition Study in Uganda
NOURISH
The Role of Nutrition as a Determinant of Immune Function and Pharmacological Outcome Amongst HIV Infected Malnourished Children in Uganda
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NOURISH
The Role of Nutrition as a Determinant of Immune Function and Pharmacological Outcome Amongst HIV Infected Malnourished Children in Uganda
Sponsor study identifier
Secondary identifiers
REGISTRY · Nutrition Study Pead.
interventional
150
1 country
2
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
February 18, 2015
Actual (reported)April 20, 2015
Actual (reported)December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes in numbers of circulating immune cell population and their capacity to release cytokines
Immune response
12 weeks
Occurrence of Immune reconstitution inflammatory syndrome (IRIS)
12 weeks
Occurrence of re-feeding syndrome
12 weeks
Pharmacological: Cmax
12 weeks
Pharmacological: AUC
12 weeks
Number of participants with adverse events
12 weeks
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
This is ready-to-use-therapeutic-food
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Infectious Diseases Institute
Kampala, Kampala, 256, Uganda
Mildmay International Centre Kampala
Kampala, Kampala, 256, Uganda
Judy Orikiiriza, MMED
PhD Candidate
First Submitted
February 18, 2015
First Posted
April 20, 2015
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 20, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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