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: pactr.samrc.ac.za
Trial no.: PACTR201602001486700 Date of Approval: 23/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Aloe and Whey Protein on HIV Enteritis
Official scientific title Evaluation of Antihelminthic Treatment and an Aloe Enriched Whey Protein Drink on Measures of HIV Enteropathy in HIV+ Children in Addis Ababa, Ethiopia
Brief summary describing the background and objectives of the trial It is now known that an early and ongoing impact of HIV infection is damage to the intestinal mucosa. This allows translocation of bacterial components into the general circulation which initiates a state of chronic immune activation which in turn impacts disease progression, and contributes to the development of multiple co-morbidities. Damage to the intestinal mucosa also impacts absorption of nutrients and contributes to compromised growth in children. Antiretrovirals are not effective at eradicating viral reserves in the intestinal tract and therefore the pathology in the gut is ongoing. Nutritional supplements incorporating amino acids and/or aloe polysaccharides have been documented to support tissue healing and attenuate release of pro-inflammatory cytokines in animal models of colitis and it is hypothesized that their daily ingestion will positively impact measures of mucosal enteropathy, bacterial translocation, immune activation, oxidative stress and clinical outcomes in HIV+ children. A 3 month randomized intervention study in HIV+ children ages 4-8 who have been on antiretrovirals for greater than 6 months will be used to explore these interventions. Albendazole will be administered to all children to address confounding abdominal parasite infections which can also damage the intestinal mucosal. Descriptive statistics, paired T tests and correlation methods will be used to analyze study data.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Other Interventions
Anticipated trial start date 01/09/2016
Actual trial start date
Anticipated date of last follow up 02/01/2017
Actual Last follow-up date 01/09/2016
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 computer generated random number table all staff working in the clinic and participating in enrollment will be blinded to interventions throughout the trial. Interventions will be disributed in numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group aloe enriched whey protein 250 mg aloe in 12 grms protein powder 3 months powdered aloe will be mixed into chocolate whey protein powder 60
Control Group Chocolate drink mix powder 2 TBLS in water daily 3 months iso-caloric control drink 60 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Enrolled at the ALERT Hospital Pediatric HIV Clinic for greater than 1 year or with complete records transferred from another Pediatric HIV Clinic. ¿Age between 4-8 years ¿History of cART for >6 months. ¿Able/willing to return to clinic weekly to collect supplement and complete weekly health history form. ¿Able/willing to participate in every 3 month extended clinic visits and blood draws ¿Able/willing to ingest study supplements ¿Any physical condition that precludes ingestion of food and study interventions ¿Suspected to have or with documented coinfection with TB disease ¿Any known cancers ¿Hx of hepatic or renal failure ¿Neurological/neuromuscular disease (cerebral palsy, muscular dystrophy, etc.) ¿Enrollment in another research study or project with medicinal or nutritional interventions ¿Children who have been on nutritional therapy (for severe wasting or PEM) in the last 6 months. ¿History of non-compliance with therapy ¿Another family or household member enrolled in same study ¿History of antihelminth treatment in last 3 months 4 Year(s) 8 Year(s) 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
No 15/03/2016 NRERC
Ethics Committee Address
Street address City Postal code Country
Addis Ababa P.O.Box 2490 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intestinal Fatty Acid Binding Protein levels Enrollment Conclusion of study (3 mths)
Secondary Outcome Endotoxin Enrollment Conclusion of 3 mth study
Secondary Outcome sCD14 Enrollment Conclusion of 3 mth study
Secondary Outcome inflammatory Cytokines, IL-1B, IL-6, TNFa Enrollment Conlusion of 3 mth study
Secondary Outcome Immune activation markers Enrollment Conclusion of 3 mth study
Secondary Outcome Immune reconstitution indicators and markers of recent thymic emigrants Enrollment Conclusion of 3 mth study
Secondary Outcome Total Oxidation Status Enrollment Conclusion of 3 mth study
Secondary Outcome Total Glutathione Enrollment Conclusion of 3 mth study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ALERT Pediatric Clinic Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Armauer Hansen Research Institute Jimma Road Addis Ababa P.O.Box 1005 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Armauer Hansen Research Institute Jimma Road Addis Ababa P.O.Box 1005 Ethiopia Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Rawleigh Howe, MD Jimma Road Addis Ababa P.O.Box 1005 Ethiopia
Mary Vander Wal Addis Ababa PO Box 127 Ethiopia
Barbara Smith 1355 Bogue Street Room C284 East Lansing, MI 48824-1315 United States of America
Meseret Gebre Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rawleigh Howe rawcraig@yahoo.com 251 910865382
City Postal code Country Position/Affiliation
Addis Ababa PO Box 1005 Ethiopia Senior Scientist AHRI
Role Name Email Phone Street address
Public Enquiries Mary Vander Wal vande521@msu.edu 251 912945698
City Postal code Country Position/Affiliation
Addis Ababa PO Box 127 Ethiopia Graduate Student/Michigan State University
Role Name Email Phone Street address
Scientific Enquiries Mary Vander Wal vande521@msu.edu 251 912945698
City Postal code Country Position/Affiliation
Addis Ababa PO Box 127 Ethiopia Graduate Student/Michigan State University
REPORTING
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