Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
Brief Summary: The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.


Options:
A: Inclusion Criteria:

* 6 to 59 months of age
* Not malnourished
* 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\*
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:

* 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
D: Inclusion Criteria:

* Term infant
* Birthweight \> 2500 g
* Healthy with no apparent congenital anomalies
* Up-to-date with vaccinations
* Hb \>10 g/dL
* Breastfeeding with intent to continue for duration of study
* Negative blood slide for malaria
* Written informed consent

Exclusion Criteria:

* Acute malnutrition
* Current or anticipated used of infant formula or other fortified products
* Current or planned use of iron (or zinc) supplements
* Previous hospitalization for malaria within the last four weeks
* Persistent diarrhea

Answer: D