Iron Bioavailability in Dana Shakti pearl millet
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202111869255513
- Lead Sponsor
- MRC Unit The Gambia at LSHTM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative bioavailability values (%RBV) of each ‘test’ millet will be calculated relative to a ferrous sulphate standardized meal (set as the nominal 100%). <br>
- Secondary Outcome Measures
Name Time Method Serum Fe before and after consumption of a test meal. <br>Transferrin saturation before and after consumption of a test meal