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.: PACTR202105499634368 Date of Approval: 06/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title MAMI-RCT Study
Official scientific title Randomized Controlled Trial to Compare the Effect of Corn-Soy Blend + Vegetable Oil and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO) on the Immunological and Microbiota Patterns among Children Aged 9 to 24 months with Moderate Acute Malnutrition (MAM)
Brief summary describing the background and objectives of the trial Corn-Soy Blend is fortified blended flour commonly used in treating Moderately Acute Malnutrition. It has high Omega-6 Polyunsaturated Fatty Acids (PUFAs), but negligible long chain Omega-3 Polyunsaturated Fatty Acids. Dietary Omega-6 promote a pro-inflammatory intestinal Microbiota and systemic inflammation, while, dietary long chain Omega-3 PUFAs are anti-inflammatory and effective in treating some inflammatory disorders. We propose that the systemic inflammation found in children with Moderately Acute Malnutrition (MAM) can be more effectively reversed through supplementary feeding that includes oil enriched in anti-inflammatory long chain Omega-3 PUFAs rather than in pro-inflammatory Omega-6 PUFAs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MAMI
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/07/2018
Actual trial start date 01/03/2019
Anticipated date of last follow up 14/07/2020
Actual Last follow-up date 15/07/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
3462 KEMRI SERU
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Corn Soy Blend and Vegetable Oil 250 grams of Corn Soy Blend and 2ml of Vegetable Oil once daily. 12 weeks 250 grams of the Corn Soy Blend provide 1,000 kilocalories. 40 Active-Treatment of Control Group
Experimental Group Corn Soy Blend and Ultimate Omega Fish Oil 250 grams of Corn Soy Blend and 2ml of Ultimate Omega Fish Oil once daily. 12 weeks 250 grams of the Corn Soy Blend provide 1,000 kilocalories. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Resident and living within Kibera Slums in Nairobi for the duration of the study. Aged 9-24 months. With MAM, defined as mid-upper arm circumference (MUAC) of 11.5 to <12.5cm. Caregiver is able and willing to provide informed consent. Severe acute malnutrition (SAM) WLZ< -3 and/or MUAC < 11.5 cm. Chronic malnutrition: Length-for-age z-score (LAZ) <-3. Clinically diagnosed severe anemia. Other chronic illnesses such as AIDS and malignancy. HIV positive; based on National Guidelines for HIV testing in Kenya. History of TB or malignancy. Clinically diagnosed active infections in the past one week such as: Pneumonia, Gastroenteritis, Urinary tract infections or Meningitis. Temperature >37.5°C. Gross Congenital abnormalities Infant: 13 Month(s)-24 Month(s) 9 Month(s) 24 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
Yes 14/06/2017 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
KEMRI Headquarters off Mbagathi Road, House Number 8 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of infectious diseases among children with moderate acute malnutrition receiving either corn-soy blend with vegetable oil and fish oil or corn-soy blend with vegetable oil alone. Baseline, 12 weeks and 6 months.
Primary Outcome Effect of corn-soy blend with vegetable oil and fish oil compared to corn-soy blend with vegetable oil alone on level of expression of inflammatory markers in children with moderate acute malnutrition. Baseline, 12 weeks and 6 months.
Primary Outcome Effect of corn-soy blend with vegetable oil and fish oil compared to corn-soy blend with vegetable oil alone on the composition of fecal microbiota. Baseline and 12 weeks.
Secondary Outcome Comparison of recovery and growth rates among children with moderate acute malnutrition receiving either corn-soy blend with vegetable oil and fish oil or corn-soy blend with vegetable oil alone. At 12 weeks and 6 months
Secondary Outcome Plasma levels of long chain omega-3 PUFAs Week 12 and month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI Centre for Clinical Research Off Mbagathi Road Nairobi 00200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenya Medical Research Institute Off Mbagathi Road Nairobi 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenya Medical Research Institute Off Mbagathi Road Nairobi 00200 Kenya State corporation
COLLABORATORS
Name Street address City Postal code Country
University of Texas Medical Branch 301 University Boulevard Galveston 0435 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Phelgona Otieno phelgona@gmail.com +254721973971 Off Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Principal Research Officer
Role Name Email Phone Street address
Public Enquiries Beatrice Olack olackb@gmail.com +254721262359 Off Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Research Officer
Role Name Email Phone Street address
Scientific Enquiries Mary Inziani inzianimatilu@gmail.com +254722523370 Off Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Paeditrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data that underlie the reported results, after de-identification (text, tables, figures, and appendices) will be made available after publication. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication with no end date. Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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