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Table 2 Inclusion and Exclusion Criteria for DHANI trial

From: The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol

Inclusion Criteria:

Exclusion Criteria:

• Pregnant woman aged 18 years to 35 years (singleton) at ≤20 weeks of gestation (calculated from the last menstrual period or by ultrasound in 1st trimester as suggested by study physician/team).

• Willing to participate in the study and provide all measurement for self, husband and the offspring including anthropometry, dietary assessment and questionnaire plus the biological samples (blood, breast milk)

• Willing to provide signed and dated written informed consent.

• Plans to deliver at the study hospital

• Willing to comply with study specific procedure/instruction

• Women with high-risk pregnancies or bad obstetric history

• Women with chronic conditions like Hypertension, heart disease, Cancer, Diabetes, epilepsy, liver disorders, thyroid problem, known history of bleeding disorders or thrombosis or any other medical condition which may affect the safety of mother/infant in opinion of study investigator/physician.

• Women allergic (if aware) to any of the test products

• Women consuming omega-3/DHA supplements or having used these in 3 months preceding the intervention period.

• Participated in another drug trial within or before 3 months from the date of screening under this study or during the study