Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India
Brief Summary: Nutritional deficiencies are a major problem in school children in India and have a variety of adverse effects on their cognitive development and growth, and increase susceptibility to infections. There is strong evidence for beneficial effects of iodine, iron and protein-energy on cognitive development in children, while evidence for vitamin B6, vitamin B12, folate, zinc and, omega-3 fatty acids and in particular docosahexanoic acid (DHA) is limited and inconclusive. A randomised, double-blind, placebo-controlled 2x2 factorial design will be conducted to assess the effect of a micronutrient with or without omega-3 fatty acids on cognitive development and performance and other selected outcome variables such as growth, morbidity and immune response in children of 7-9 years of age in India.


Options:
A: Inclusion Criteria:

1. Children aged 7to 9 years, not having their tenth birthday close to the start of the study
2. Children attending the primary schools in Bangalore area in India which are selected in the cross-sectional survey
3. Healthy as assessed by a physician
4. Willing to consume the test product
5. Willing to participate in the study and perform all measurements including cognitive testing, blood drawing, urine samples, anthropometry, dietary intake and questionnaires.
6. Informed consent signed by parent or caregiver and oral consent given by child
7. Parents intend to stay in the study area for less than 1 year.

Exclusion Criteria:

1. Children with obvious mental and physical handicaps
2. Children using medication which interferes with study measurements
3. Reported dietary restrictions such as a medically prescribed diet, or a slimming diet prior to or during the study
4. Severely undernourished as defined by HAZ, WAZ or WHZ greater than -3 SD from NCHS reference standard z-scores (Ogden et al, 2002)
5. Severely iron deficient as defined by hemoglobin concentrations \<80 g/L (WHO, 2001)
6. Reported participation in another biomedical trial 3 months before the start of the study or during the study.
B: Inclusion Criteria:

* signed informed consent by parent / caretaker
* age between 6 and 14 yrs
* visiting selected school
* taking part in school meal program

Exclusion Criteria:

* any chronic illness affecting growth (such as HIV)
* no informed consent
* severe anemia which will require direct treatment
C: Inclusion Criteria:

* Children aged 12-36 months at enrollment
* Resident of Sangam Vihar and likely to be in the area for 1 year.
* Parents consenting to participate in the trial.

Exclusion Criteria:

* Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
* Children currently as part of a different Iron/Zinc supplementation program.
* Children known to be allergic to milk.
* Children who are severely malnourished and requiring hospitalization.
D: 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

Answer: A