Please select the eligibility criteria that correspond to the clinical trial below.
Title: Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Brief Summary: The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.


Options:
A: Inclusion Criteria:

* 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.

Exclusion Criteria:

* loss of appetite,
* oral lesion,
* congenital anomaly/acquired disorder affecting growth,
* severe acute malnutrition (SAM) defined by:

  * MUAC \< 115 mm or
  * WL \< -3 Z score or
  * bipedal edema,
  * persistent diarrhea,
  * tuberculosis,
  * any other chronic illness.
B: Inclusion Criteria:

Recruitment and primary eligibility criteria:

* Age \> 14 years.
* Ability to give informed assent or consent.
* Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
* Currently pregnant (with a single or multiple fetuses).
* Gestation \< 30 weeks at referral from 'Call to Action' Program
* No serious current complications of pregnancy.
* Intention to breastfeed.
* Intention to deliver at the institution at which the study is based.
* Not previously enrolled in this study for an earlier pregnancy.
* Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses.
* No previous use of antiretrovirals including the HIVNET 012 regimen.
* Mother's CD4 count \> 250 cells/uL determined in the antenatal clinic.
* Mother's ALT \< 2.5 x ULN (upper limit of normal) determined in the antenatal clinic

Secondary eligibility criteria and treatment assignment:

* Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery.
* Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant.
* Infant birth weight \> 2000 g.
* No severe congenital malformations or other condition(s) not compatible with life.
* Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.
C: Cross-sectional study (baseline and endline)

Inclusion Criteria:

* At least one index child 6-23 months of age in the household
* Mother should be living in the study area since the index child's delivery
* Singleton infants

Exclusion Criteria:

* Index child should not present congenital deformations that hamper anthropometric measurements

Longitudinal study

Inclusion Criteria:

* Child 6-6.9 months of age;
* Child with WHZ\>-2 and MUAC\>125 mm and no bilateral pitting edema
* Mother should be living in the study area since the index child's delivery
* Singleton infants

Exclusion Criteria:

* Congenital malformations that make anthropometric measurements impossible
* Mother planning to leave the study are in the coming year
D: Inclusion Criteria:

* Confirmed maternal HIV-infection
* Age 5.5-6.5 months at intervention start
* Weight-for-length z-score \> -3 SD (WHO 2006 reference)

Exclusion Criteria:

* Confirmed or suspected allergy to peanuts
* Participation in a concurrent clinical trial at GHESKIO

Answer: A