Khandelwal 2012.

Trial name or title	Effect of Docosa‐Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India: (DHANI)
Methods	RCT: NCT 01580345.
Participants	Recruitment target: 600 women Inclusion criteria: 18 to 35 years or older; ≤ 20 weeks of gestation; willing to participate in the study and perform all measurements for self, husband and offspring; willing to provide signed and dated informed consent. Exclusion criteria: allergic (if aware) to any of the test products; at high risk for hemorrhagic bleeding, clotting (if aware); high‐risk pregnancy; consuming omega‐3 supplements or having used these in 3 months preceding the intervention period; reported participation in another biomedical trial 3 months before the start of the study or during the study. Setting: KLEUs Jawaharlal Nehru Medical College, Prabhakar Kore Charitable Hospital, Belgaum, Karnataka, India.
Interventions	Intervention group 400 mg of DHA daily, from ≤ 20 weeks' gestation until birth. Control group 400 mg/day of placebo (corn/soy oil), from ≤ 20 weeks' gestation until birth.
Outcomes	Primary outcomes: newborn anthropometry (birthweight, length, and head circumference). Other outcomes: gestational age; new born APGAR score (at 1 minute and 5 minutes); unfavourable pregnancy outcomes (stillbirth, low birthweight babies, and preterm babies)
Starting date	December 2015
Contact information	Dr Shweta Khandelwal, Senior Public Health Nutritionist, Centre for Chronic Disease Control, India. E‐mail: shweta.khandelwal@phfi.org
Notes	Funding and collaborators: Centre for Chronic Disease Control, India; Department of Science and Technology, Government of India; Jawaharlal Nehru Medical College.