Nutritional, Metabolic, Endocrine
Conditions
Interventions
Pearl millet Gambian strain locally sourced
pearl milllet strain dana shakti locally sourced
Sponsors
MRC Unit The Gambia at LSHTM
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative bioavailability values (%RBV) of each ‘test’ millet will be calculated relative to a ferrous sulphate standardized meal (set as the nominal 100%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Fe before and after consumption of a test meal. Transferrin saturation before and after consumption of a test meal | — |
Countries
Gambia
Contacts
Public ContactElizabeth Stanley Batchilly
Head of Governance and Research Support Services
Outcome results
None listed