Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Research Plan for a Randomised, Single-blind, Parallel Group Controlled Trial in Rural Malawi, Testing the Health Effects of Supplementing Maternal Diet During Pregnancy and Lactation and Infant Diet From 6 to 18 Months of Age With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Brief Summary: The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only.

To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.


Options:
A: Inclusion Criteria:

* Gestational age ≤ 20 weeks
* Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area)

Exclusion Criteria:

* Pregnancy identified and registered in the CHDP program before the beginning of the enrollment.
B: Inclusion Criteria:

* HIV infected
* CD4 count \> 200 cells/μL
* ALT \< 2.5 x upper limit of normal (ULN)
* Hemoglobin (Hb) \> 7 g/dL
* Age \> 18 years, or \<18 years and married (considered emancipated minors in Malawi)
* Ability to give informed consent
* Evidence of HIV infection, as documented by 2 positive Enzyme-Linked Immunosorbent Assays (ELISA's); or 1 positive ELISA, and 1 Western blot (WB); or 2 separate concurrent rapid tests. These are the World Health Organization (WHO) acceptable criteria for diagnosing HIV-1 infection in adults.
* Currently pregnant (with a single or multiple fetuses)
* Gestation \< 34 weeks
* No serious current complications of pregnancy
* Intention to breastfeed
* Intention to deliver at the institution in which the study is based
* 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
C: Inclusion Criteria:

* Ultrasound confirmed pregnancy of no more than 20 completed gestation weeks
* Permanent resident of Mangochi District Hospital, Malindi Hospital or Lungwena Health Centre catchment areas
* Availability during the period of the study
* Signed informed consent

Exclusion Criteria:

* Less than 15 years of age
* Need for frequent medical attention due to a chronic health condition
* Diagnosed asthma treated with regular medication
* Severe illness warranting hospital referral
* History of allergy towards peanuts
* History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
* Pregnancy complications evident at enrolment visit (moderate to severe oedema, blood Hb concentration \< 5 g / dl, systolic blood pressure (BP) \> 160 mmHg or diastolic BP \> 100 mmHg)
* Earlier participation in the iLiNS-DYAD-M trial
* Concurrent participation in any other clinical trial
D: Inclusion Criteria:

* At least 18 years of age
* No more than 20 wk of gestation
* Given Ante-natal Cards of the Ghana Health Service
* Completed the initial routine ante-natal examination at the clinics
* HIV negative or status unknown (as from the Ante-natal card)
* Free from chronic disease e.g. malignancy requiring frequent medical attention (as from the Ante-natal card)
* Residing in the Manya Krobo or Yilo Krobo district
* Prepared to sign an informed consent
* Living in the area throughout the duration of the study
* Acceptance of home visitors

Exclusion Criteria:

* Known asthmatic or history of allergy towards peanut or milk products
* Concurrent participation in another clinical trial
* Severe illness warranting hospital referral

Answer: C