Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial
Brief Summary: This study will determine whether the haemoglobin response to daily home fortification for 30 days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous fumarate.


Options:
A: 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\*
B: Inclusion Criteria:

* Signed informed consent from at least one parent or primary caregiver
* Age 6-23 months initially
* Permanent resident of study area
* Planned availability during the period of the study
* Acceptance of home visitors

Exclusion Criteria:

* Weight-for-height z-score (WHZ) \<-3Z with respect to WHO 2006 standards
* Presence of bipedal edema
* Severe illness warranting hospital referral
* Congenital abnormalities potentially interfering with growth
* Chronic medical condition (e.g. malignancy) requiring frequent medical attention
* Known HIV infection of index child or child's mother
* Hemoglobin \<70 g/L
* Currently consuming zinc supplements
* Current participation in any other clinical trial
C: 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
D: 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).

Answer: D