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.: PACTR202308825529445 Date of Approval: 10/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Acceptability of a maternal ready-to-use supplementary food containing fish oil and choline in Sierra Leone
Official scientific title Acceptability of a maternal ready-to-use supplementary food containing fish oil and choline in Sierra Leone
Brief summary describing the background and objectives of the trial Undernutrition in pregnancy is common, affecting nearly 10% of women worldwide and 25% of women in Sub-Saharan Africa, and increases risks for both mothers and their offspring, including bleeding, preterm birth, neonatal mortality, and impaired infant cognitive development. Available treatments have limited impact on these outcomes, which affect millions annually. Studies in well-nourished pregnant women suggest antenatal supplementation with docosahexaenoic acid (DHA) prolongs gestation and reduces early preterm birth, but its effects in undernourished populations are unclear. There is also evidence that antenatal DHA supplementation might promote offspring cognitive development in certain settings. In addition, ante- and postpartum depression are underrecognized and undertreated in rural Sub-Saharan Africa. There is some evidence that eicosapentaenoic acid (EPA) supplementation might improve depression. There is a planned efficacy trial (COGENT, PACTR202306540202462) designed to determine whether antenatal provision of a maternal ready-to-use supplementary food with added DHA, EPA, and choline (M-RUSF+) might prolong gestation, improve infant cognitive development, and improve ante- and post-partum depression among undernourished pregnant Sierra Leonean women when compared with a similar maternal ready-to-use supplementary food, but without added DHA, EPA, and choline (M-RUSF). In anticipation of COGENT, this trial aims to determine the acceptability of M-RUSF+ vs. M-RUSF in pregnant Sierra Leonean women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Acceptability of a novel ready-to-use maternal supplementary food
Anticipated trial start date 11/07/2023
Actual trial start date 11/07/2023
Anticipated date of last follow up 28/07/2023
Actual Last follow-up date 28/07/2023
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
015032023 Sierra Leone Ethics and Scientific Review Committee
202303142 Washington University in St. Louis Human Research Protection Office
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Maternal ready to use supplementary food with added DHA EPA and Choline 1 packet per day 1 week A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein Ready-to-Use Supplementary Food (M-RUSF+). One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/WHO/UN multiple micronutrient supplement for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food. 50
Control Group Maternal ready to use supplementary food without added DHA EPA choline 1 packet per day 1 week A balanced energy-protein maternal Ready-to-Use Supplementary Food (M-RUSF) without added DHA/EPA/choline. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/WHO/UN multiple micronutrient supplement for pregnant/lactating women. M-RUSF will be vacuum sealed and packaged in foil sachets containing 100g of food. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. At least 16 years of age 2. Pregnant 3. Not expecting to deliver in next 2 weeks 4. Stated willingness of comply with study procedures and availability during the study, with no plan to move in subsequent 3 weeks 1. Allergy to ingredient in food, including peanut, milk, fish, soy, or millet 2. Receiving a separate supplementary food product from another organization 3. Current participation in separate research study 4. Indication for immediate hospitalization Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
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 09/03/2023 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Directorate of Training and Research, 5th Floor, East Wing, Youyi Building, Brookfields Freetown NA Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of study food consumed 3 and 7 days after initiation of each food
Secondary Outcome Likeability score, scores range from 1-5 with 5 indicating greatest level of likeability 3 and 7 days after initiation of each food
Secondary Outcome Reported vomiting 3 and 7 days after initiation of each food
Secondary Outcome Reported diarrhea 3 and 7 days after initiation of each food
Secondary Outcome Reported rash 3 and 7 days after initiation of each food
Secondary Outcome Manner in which participant prepared the study foods for consumption 3 and 7 days after initiation of each food
Secondary Outcome Number of days over which study food was consumed 3 and 7 days after initiation of each food
Secondary Outcome Number of days that the participant wished they had more study food to consume 3 and 7 days after initiation of each food
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zimmi NA NA NA Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
Open Philanthropy 182 Howard Street 225 San Francisco 94105 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Washington University in St. Louis 1 Brookings Drive Saint Louis 63130 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Sierra Leone Ministry of Health and Sanitation 4th and 5th floors, Youyi Building Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Manary manarymj@wustl.edu +13144542341 600 South Euclid Avenue
City Postal code Country Position/Affiliation
St. Louis United States of America Professor of Pediatrics
Role Name Email Phone Street address
Public Enquiries Donna Wegner donnarwegner@wustl.edu +13144547162 600 South Euclid Avenue
City Postal code Country Position/Affiliation
St. Louis 63110 United States of America Project Manager in the Department of Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Kevin Stephenson k.stephenson@wustl.edu +13144545685 600 South Taylor Avenue, Suite 155
City Postal code Country Position/Affiliation
St. Louis 63110 United States of America Instructor of Medicine
Role Name Email Phone Street address
Scientific Enquiries Aminata Koroma shamitamin@gmail.com +23276300770 Jomo Kenyatta Road
City Postal code Country Position/Affiliation
Freetown Sierra Leone Director of Food and Nutrition in the Sierra Leone Ministry of Health and Sanitation
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be available. All of the individual participant data collected during the trial will be shared, after deidentification. The study protocol, statistical analysis plan, informed consent form, and analytic code will be shared. The data will be available within 12 months of the primary trial publication. Anyone who wishes to access the data will have access, for any type of analysis purpose. The data will be posted on a public repository. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of primary trial publication None
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