Child Nutrition DisordersNOURISHNCT02421302
The Pediatric HIV Nutrition Study in Uganda
A study testing RUTF in people with Child Nutrition Disorders, run by Infectious Diseases Institute at 2 sites in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Child Nutrition Disorders
- What is being tested?
- RUTF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUganda
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites, 2 recruiting
- Recruiting
Infectious Diseases Institute
Kampala, Kampala, 256
Mohammed Lamorde, PhD, +256312307000 ext. 320, mlamorde@idi.co.ug
Allen M Mukhwana, MBA, +256312307000 ext. 242, amukhwana@idi.co.ug
- Recruiting
Mildmay International Centre Kampala
Kampala, Kampala, 256
Judy Orikiiriza, MMED, +256307000 ext. 244, jorikiiza@idi.co.ug
Jane Nakaweesi, MMED, +256 312 210 200, nakawesijane@gmail.com
About this study
Official title: The Role of Nutrition as a Determinant of Immune Function and Pharmacological Outcome Amongst HIV Infected Malnourished Children in Uganda
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.
Read the 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.
- Conditions
- Child Nutrition Disorders
- Being tested
- RUTF
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTFDietary supplement
Also called Ready-to-Use-Therapeutic-Food
This is ready-to-use-therapeutic-food
| Study group | Role | What they receive |
|---|---|---|
| Well-nourished HIV+ ART naive | No intervention | 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 |
| Moderately-malnourished HIV+; RUTF | Active comparator | 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 Receives: Dietary Supplement: RUTF |
| Severely acute-malnourished HIV+; RUTF | Active comparator | 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 Receives: Dietary Supplement: RUTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in numbers of circulating immune cell population and their capacity to release cytokines
Immune response
Measured: 12 weeks
Secondary outcomes (5)
Occurrence of Immune reconstitution inflammatory syndrome (IRIS)
Episodes of Opportunistic infections - Clinical outcomes
Measured: 12 weeks
Occurrence of re-feeding syndrome
Episodes of Opportunistic infections - Clinical outcomes
Measured: 12 weeks
Pharmacological: Cmax
Cmax of Non-nucleotide reverse - transcriptase inhibitors (NNRTI) and Protease Inhibitors(PIs) at 0weeks, 6weeks,12weeks
Measured: 12 weeks
Pharmacological: AUC
Area Under Curve (AUC) Time Frame: 0weeks, 6weeks, 12weeks for nevirapine and lopinvir/retonavir
Measured: 12 weeks
Number of participants with adverse events
Pharmacological: Number of participants with adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infectious Diseases Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Responsible party
- Sponsor-investigator, Infectious Diseases Institute, Makerere University
- Investigators
- Judy Orikiiriza, MMED, Principal investigator, PhD Candidate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421302
- Sponsor's protocol ID
- ST/0110/15
- Other IDs
- ST/0110/15
- Acronym
- NOURISH
- Status last verified
- Apr 2015
- First submitted
- 18 Feb 2015
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nutrition as a Determinant of Immune Function and Pharmacological Outcome Amongst HIV Infected Malnourished Children in Uganda
- ClinicalTrials.gov ID
- NCT02421302
- Acronym / sponsor ID
- NOURISH / ST/0110/15
- Conditions
- Child Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Infectious Diseases InstituteUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Well-nourished HIV+ ART naive | No intervention | –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 |
| Moderately-malnourished HIV+; RUTF | Active comparator | Dietary Supplement: RUTFThese 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 |
| Severely acute-malnourished HIV+; RUTF | Active comparator | Dietary Supplement: RUTFThese 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 |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUTFAlso: Ready-to-Use-Therapeutic-FoodThis is ready-to-use-therapeutic-food | Dietary supplement | Moderately-malnourished HIV+; RUTF, Severely acute-malnourished HIV+; RUTF |
Primary outcome
Changes in numbers of circulating immune cell population and their capacity to release cytokines
Time frame: 12 weeks
Immune response
5 secondary outcomes
Occurrence of Immune reconstitution inflammatory syndrome (IRIS)
Time frame: 12 weeks
Occurrence of re-feeding syndrome
Time frame: 12 weeks
Pharmacological: Cmax
Time frame: 12 weeks
Pharmacological: AUC
Time frame: 12 weeks
Number of participants with adverse events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Orikiiriza, MMED principal investigator
PhD Candidate
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RUTF in people with Child Nutrition Disorders, run by Infectious Diseases Institute at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judy Orikiiriza, MMED (+256312307000 ext. 224, jorikiiriza@idi.co.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in numbers of circulating immune cell population and their capacity to release cytokines (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.