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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201207000371218 Date registered: 2012/03/26
TRIAL DESCRIPTION
Public title EFFICACY OF GLUTAMINE SUPPLEMENTATION ON THE OUTCOME OF CHILDREN ADMITTED WITH PERSISTENT DIARRHEA
Official scientific title EFFICACY OF GLUTAMINE SUPPLEMENTATION ON THE OUTCOME OF CHILDREN ADMITTED WITH PERSISTENT DIARRHEA TO MULAGO HOSPITAL
Brief summary describing the background
and objectives of the trial
Persistent diarrhea represents 10% of diarrhea episodes but 50% of deaths. Its bad effects are due to prolonged intestinal injury hence increased permeability, delayed regeneration and passage of bacteria into the blood. Glutamine has improved diarrhea due to nelfinavir and chemotherapy. Objectives: Primary; assess the efficacy of glutamine supplementation in children 2-59 months on the proportion who fail to improve. Secondary;To assess glutamine efficacy on the duration of persistent diarrhea
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 2011-09-26
Actual trial start date 2011-10-03
Anticipated date of last follow up 2012-03-26
Actual date of last follow up 2012-03-26
Anticipated target sample size (number of participants) 138   
Actual target sample size (number of participants) 140   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
REC REF 2011-176 School of medicine Ethics and Research committee, Makerere University College of Health sciences.

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised The randomization schedule was generated by a statistician using a computer soft ware. The schedule consisted of random numbers and the assigned intervention to be administered. The random numbers and assigned intervention was written on a piece of paper and was sealed in an opaque envelope. Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Glutamine powder 150mg/kg/dose 12 hourly. up to a maximum of 12 days White powder, odourless and tasteless and does not change colour on dissolving - will be placed in rice porridge at 132g/kg/24hrs in 8 divided doses 69
Control group Control/Standard of Care rice porridge alone at 132ml/kg/24hrs in 8 divided doses up to a maximum of 12 days rice porridge at 132g/kg/24hrs in 8 divided doses 69 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Children aged between 2 and 60 months 2. Children admitted with persistent diarrhea during the study period. 3. Written informed consent from the caregivers/parents 1. Children with documented anti-diarrhea medications (e.g antimotility, opiates) 2. Children with documented liver disease or Renal disease. 2 Months 60 Months Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes School of medicine Ethics and Research committee Makerere University college of Health sciences.
Ethics Committee Address
Street address City Postal code Country
Mulago hill road kampala Box 7072 kampala,Ug Uganda

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the proportion of children who fail to improve Daily

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Paediatric Emergency unit of Mulago Hospital Mulago Hill road Kampala Uganda

FUNDING SOURCES
Name of source Street address City Postal code Country
Micro Research Halifax Canada

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Micro Research Halifax Canada Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Prof. Bortolussi Bob Halifax Canada
Assoc. Prof. Sarah Kiguli Makerere University college of health sciences, department of pediatrics kampala Uganda

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Justine Kamuchaki mkamuchaki@gmail.com +256772383833
Street address City Postal code Country Position / Affiliation
kampala Uganda Graduate student/ makerere University
Role Name Email Phone Fax
Public Enquiries Dr Justine Kamuchaki mkamuchaki@gmail.com +256772 383 833
Street address City Postal code Country Position / Affiliation
Kampala Uganda Graduate student makerere university
Role Name Email Phone Fax
Public Enquiries Dr Justine Kamuchaki mkamuchaki@gmail.com +256772 383 833
Street address City Postal code Country Position / Affiliation
Kampala Uganda Graduate student makerere university