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.: PACTR202111869255513 Date of Approval: 05/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Iron Bioavailability in Dana Shakti pearl millet
Official scientific title Iron Bioavailability in Dana Shakti pearl millet
Brief summary describing the background and objectives of the trial It is an unblinded clinical trial, with 60 nonpregnant women of reproductive age. Each woman will each consume three test meals prepared with millet and one containing 60mg elemental iron on four different study days (Days 1, 8, 15 and 22). Each woman will serve as her own control.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Iron Ladies
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Serum iron 5 hours after consumption of test meal.
Anticipated trial start date 01/05/2021
Actual trial start date 27/07/2021
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date 15/09/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 57
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
19168 Medical Research Council The Gambia Scientific Coordinating Committee
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pearl millet Gambian strain locally sourced Rural Gambian women between 18-50 years of age 3 times 22 days 3 dialy ‘test’ meals and one ‘REFERENCE’ meal Formulation of REFERENCE meal: 10-15mg/day of Elemental iron 60
Control Group pearl milllet strain dana shakti locally sourced Rural Gambian women between 18-50 years of age once 22 An unblinded clinical trial with 60 non pregnant women of reproductive age. Each woman will each consume three test meals prepared with millet and one containing only ferrous sulphate on four different study days (Day 1,8,15 and 22). Each woman will serve as her own control. 60 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women between the ages of 18-50 Not pregnant Willingness to reside in the study site area for the length of the study and are able and willing to adhere to all protocol Healthy with no current illness and no chronic health problems, asked verbally by field worker Signed or fingerprinted informed consent obtained Acute illness (once the acute illness is resolved, if appropriate, as per investigator assessment, the participant may be re-evaluated for eligibility) Fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3days prior to study initiation (once fever/acute illness is resolved, if appropriate, as per investigator assessment. The participant may be re-evaluated for eligibility) Administration of any investigational drug within 30 days prior to study initiation or planned administration during the study period Unwilling to avoid the ingestiob of supplements or herbal/other traditional medications during the study period Any history of evidence for chronic clinically significant (as per investigator assessment) disorder or disease (included, but not limited to, immunodeficiency, autoimmunity, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease Any history of human immunodeficiency virus, chronic hepatitis B or chronichepatitis C infections History of meningitis, seizures, Guillain-Barre syndrome, or other neurological disorders Any condition that in the opinion of the investigator might compromise the safety or well-being of the participant or compromise adherence to protocol procedures Adult: 19 Year-44 Year 18 Year(s) 56 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 21/09/2020 The Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Atlantic Road Banjul 00220 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Relative bioavailability values (%RBV) of each ‘test’ millet will be calculated relative to a ferrous sulphate standardized meal (set as the nominal 100%). 5 hours after consumption of test meal
Secondary Outcome Serum Fe before and after consumption of a test meal. Transferrin saturation before and after consumption of a test meal Before and after consumption of a test meal
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRC Unit The Gambia Keneba Field Station Atlantic Boulevard, Fajara, P.O. Box 273P.O. Box 273 Banjul 00220 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
UKRI Polaris House, Swindon London SN2 1FL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MRC Unit The Gambia at LSHTM Atlantic Boulevard, Fajara, P.O. Box 273P.O. Box 273 Banjul 00220 Gambia Research Institution
COLLABORATORS
Name Street address City Postal code Country
Ms Haddy Crookes Bertil Harding Highway Banjul 00220 Gambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Carla Cerami ccerami@mrc.gm 4495442 Atlantic Boulevard
City Postal code Country Position/Affiliation
Banjul 00220 Gambia Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Carla Cerami ccerami@mrc.gm 4495442 Atlantic Boulevard
City Postal code Country Position/Affiliation
Banjul 00220 Gambia Principal Investigator
Role Name Email Phone Street address
Public Enquiries Elizabeth Stanley Batchilly esbatchilly@mrc.gm 4495442 Atlantic Boulevard
City Postal code Country Position/Affiliation
Banjul 00220 Gambia Head of Governance and Research Support Services
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A summary of the trial results, based on the clinical study report and/or peer reviewed publication will be provided within 12 months of study completion as expected’ Study Protocol within 12 months of study completion The study data will be stored in a limited access, password protected database so that only staff who have the required permissions can view the study records
URL Results Available Results Summary Result Posting Date First Journal Publication Date
when results available 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