Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya
Brief Summary: Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food.

The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants.

Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.


Options:
A: Inclusion Criteria:

1. Aged 12-36 months;
2. Residing in the study area;
3. Planning to be in the area for the duration of the intervention and follow-up;
4. Study protocol accepted and informed consent given by at least one parent or guardian

Exclusion Criteria:

1. Known or reported allergy to dihydroartemisinin, piperaquine, benzimidazole drugs or praziquantel;
2. A sibling from the same household already randomised to intervention;
3. Severely malnourished (weight-for-height z-score \< -3 SD) (for ethical reasons);
4. Presence of fever (axillary temperature ≥ 37.5 ºC) (to avoid inflammation-induced effects on iron status markers);
5. Presence of reported or suspected systemic disorder (e.g. HIV infection, sickle cell disease) (to avoid inflammation-induced effects on iron status markers and to avoid attrition);
6. Missed one or several doses of the 3-day course of dihydroartemisinin-piperaquine (to ensure that participants are protected against malaria for the duration of the iron intervention);
7. No blood sample collected, or blood volume collected \< 5 mL;
8. Haemoglobin concentration \< 70 g/L (to prevent severe anaemia).
B: 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
C: Inclusion Criteria:

* Aged 12-59 months at the time of entry into the study
* Resident in village for at least 6-months and the caretaker plans to remain in the area for the next year
* Apparently healthy at the time of entry into the study

Exclusion Criteria:

* Severe anaemia i.e. Hb concentration \<70 g/L (See section 5.5)
* Taking iron containing haematinic supplements
* Transfused in the last six months
* Severely undernourished i.e. anthropometric indices \<-3 Z score
D: Inclusion Criteria:

* Children of ages 2 weeks to 6 months for recruitment into the Trial. Children of ages 6 months and onwards would eligible to receive intervention (in the form of Micronutrient Sprinkles)

Exclusion Criteria:

* Children with obvious congenital anomalies.

Answer: B