Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
Brief Summary: Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification.

Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya.

Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study.

Study design:

The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks.

Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups.

Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories.

Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration \<12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of \>8.3mg/L. Infection will be assessed by raised CRP (\>10mg/L) as an indicator of acute inflammation and presence of malaria.


Options:
A: 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
B: Inclusion Criteria:

* at least 18 years of age
* in first trimester of pregnancy
* plans to reside in the same village during the entire pregnancy

Exclusion Criteria:

* a minor
* not in first trimester of pregnancy
* plans to relocate during the pregnancy
C: Inclusion Criteria:

* Inclusion criteria for clusters: Each cluster will be a rural community characterized by inhabitants with low income and served by one community health center. A primary criterion is that national or other available statistics indicate a prevalence of stunting (mean length for age Z-scores in second year \< -2) of at least 20% in young children.
* Inclusion criteria for individual families:

  * Infant aged 3-4 months;
  * Primarily or exclusively breast feeding with intent to continue breast feeding through at least 1 year.

Exclusion Criteria:

* Exclusion criteria for individual families: Exclusion criteria include any population/family that is receiving or likely to receive free or subsidized complementary foods (or infant formula) through the health system or NGOs; any individual families who are feeding or intend to feed fortified infant formula or micronutrient-fortified commercial complementary foods.
* Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation:

  1. known congenital anomaly;
  2. infant of multiple births;
  3. known neurological deficit apparent at the time of enrollment (including seizures).
D: Inclusion Criteria:Children:

* 3-8 years age (for the purposes of this study this will include children born within the period December 15th 1995- May 1st 2001).
* Whohave been resident in the area for 6 months or more.
* Enrolled in the selected schools
* Able to consume the target amount of porridge, at least 50% of the time during the run-in period
* Will be present in the study area for the entire study period (April - December 2004).

Exclusion Criteria:

* Children below 3 years and above 8 years of age (born after December 15th 1995 and before May 1st 2001).
* Children who have been resident in the area for less than 6 months at the time of recruitment.
* Children with obvious physical and mental disability.
* Severely malnourished children.
* Severely anaemic children (Hb \<70g/L).

Answer: A