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.: PACTR202311714091884 Date of Approval: 10/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children at Risk of Malnutrition.
Official scientific title The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children at Risk of Malnutrition.
Brief summary describing the background and objectives of the trial Environmental Enteric Dysfunction (EED), a subclinical infection from enteric pathogens thrives in conditions of poor sanitation and hygiene. It is a critical causal component of undernutrition and stunting in infants in low resources countries as it reduces the efficacy of nutritional interventions to restore normal and catch-up growth. Protein supply is a major contributor to normal and catch-up growth. Few data are available on the impact of EED on protein digestion and amino acid absorption and metabolic availability to support growth. Children with EED may have higher IAA requirements than healthy children because indispensable amino acids (IAAs) are required for intestinal mucin production and intestinal repair. It is recommended that nutritional interventions to optimize recovery from EED should contain IAAs to ‘replenish depleted stores. However, the ideal IAA profile for such an intervention is unknown. Thus, the overarching goal is to assess the impact of supplementation with indispensable amino acids (IAAs) on environmental enteropathy among children at risk of stunting.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 11/07/2023
Actual trial start date 03/10/2023
Anticipated date of last follow up 13/08/2024
Actual Last follow-up date 28/02/2025
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group CTom 3 times per week 28 Days Cereals (maize, millet, rice) food with protein (fish and soya beans) 40 Dose Comparison
Experimental Group TomAA 3 times per week 28 Days Cereals (Maize, milet, rice) food with protein (fish, soya Beans) + Indispensable Amino Acids + H-AA (labelled deuterium Amino Acid) +U-13C-spirulina + Gly-Sar 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18-36 months old Stunted (LAZ<-2) Of either sex Able and willing to undergo HIV testing. Parent, primary caregiver or guardian able and willing to give written, informed consent. Have had diarrhea (by self-report) in the preceding month. Sibling or twin of another participating study child Have any underlying condition other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 18 Month(s) 36 Month(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 06/09/2023 Ghana Health Service Ethics Review
Ethics Committee Address
Street address City Postal code Country
Cathedral Square Castle Road Accra MB190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Determine the effect of indispensable amino acid supplementation on change in gut permeability as assessed by the L/R ratio. From Baseline to Endline
Secondary Outcome Determine the effect of indispensable amino acids supplementation on the change in gut digestive capacity as assessed by the C-13 sucrose breath test. from baseline to endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Princess Marie Louise Children Hospital Keteke Sub-metro Accra GP112 Ghana
Dome Konka Preschools Dome Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
International Atomic Energy Agency Vianna International Centre Vienna A-1400 Austria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Atomic Energy Agency Vienna International Centre Vienna A-1400 Austria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Mame Yaa Nyarko Accra Metropolis Accra GP112 Ghana
Sarita Devi Sarjapur Road, Koramangala Bangalore 560034 India
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seyram Achoribo elom.achoribo@gaec.gov.gh +233243674503 Neutron Street
City Postal code Country Position/Affiliation
Accra 80 Ghana Senior Research Scientist
Role Name Email Phone Street address
Public Enquiries Yaa Akomea yaa.akomea@gaec.gov.gh +233545081957 ACP Road
City Postal code Country Position/Affiliation
Accra 80 Ghana Technologist
Role Name Email Phone Street address
Scientific Enquiries Deborah Nuro Ameyaw deborah.nuro-ameyaw@gaec.gov.gh +233505258977 Accra
City Postal code Country Position/Affiliation
Accra Ghana Research Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This study's data may be shared with qualified researchers with an academic interest in nutrition. Data provided upon request or retrieved from the funder's website (IAEA) will be coded. Clinical Study Report Within 1 year after completing the study Data Access will be controlled by the Funding Agency and request can be made through the Principal Investigator to the Agency.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information