Please select the eligibility criteria that correspond to the clinical trial below.
Title: Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa
Brief Summary: Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. The investigators recently finished a randomized, double blind controlled intervention trial in Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement the intervention study, the present study will compare iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. A stool sample will be collected at baseline and on the first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron absorption from the iron and GOS containing MNP will inform decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still cover the infant requirement for absorbed iron.


Options:
A: Inclusion Criteria:

* Age 6-24 months
* Ingesting weaning food in addition to breastmilk
* Free from malaria or other major illnesses
* Afebrile
* Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up

Exclusion Criteria:

* Severe anemia (hemoglobin \<70g/L)
* Weight-for-height \<-3 z-score(severe wasting)
* Kwashiorkor (defined as evidence of edema)
* Congenital abnormality
* Treatment with iron supplements within the past 6 months
* Presence of any chronic illness
B: Inclusion Criteria:

* Age of 6-14 months at baseline
* Assessment of good health as assessed by professional staff at Msambweni District Hospital
* Willingness of their caregiver to provide informed consent

Exclusion Criteria:

* Hemoglobin \<70 g/L ; these infants will be referred for treatment according to local standard of care.
* Severe underweight (Z-score weight-for-age \<-3) and /or severe wasting (Z-score weight-for-height\<-3)
* Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
* Participants taking part in other studies requiring the drawing of blood
* Participants who are taking iron-containing food supplements or tablets/drops
* Participants who are taking antibiotics
C: Inclusion Criteria:

* 6 to 59 months of age
* Not malnourished or moderately acutely malnourished children
* Diagnosis of malaria and/or diarrhoea and/or LRTI
* Intending to remain in area for the duration of the 6 month follow-up
* Living within approximately 60 minutes walking distance from the clinic
* Informed consent from a guardian\*

Exclusion Criteria:

* Child is exclusively breastfeeding
* Child is severely malnourished
* Presence of 'General Danger Signs'
* Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
* Needing hospitalisation for any reason
* Known history of allergy to the nutritional supplementation
* Having a sibling enrolled in the study\*
D: Inclusion Criteria:

* Mother at least ≥15 years of age, infants 5.5- 6.5 months
* Willingness to provide informed consent
* Apparent good health
* Long-term residence in study site and anticipating residing in the area for at least 3 years
* Speak a Mjikenda language or Kiswahili in the home
* Willingness to provide blood samples during clinic visits

Exclusion Criteria:

* Hemoglobin \<70 g/L for infants; these infants will be referred for treatment at the local health clinic/hospital.
* Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition or any other finding that in the opinion of the PI or co-researchers that would increase risk of participating in the study.
* Other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol

Answer: B