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. 2018 Nov 15;2018(11):CD003402. doi: 10.1002/14651858.CD003402.pub3

Kodkhany 2017.

Trial name or title Maternal DHA Supplementation and Offspring Neurodevelopement in India (DHANI‐2)
Methods RCT: NCT03072277
Participants 957 participants
Inclusion criteria: 18 to 35 year old pregnant women (singleton) at ≤ 20 weeks GA, willing to participate in study and perform all measurements for self, husband and offspring including anthropometry, dietary assessment, questionnaires and biological samples (blood and breast milk), willing to provide signed and dated informed consent
Exclusion criteria: allergic (if aware) to any of the test products, at high risk for haemorrhagic bleeding or clotting (if aware), high‐risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, pre‐eclampsia, pregnancy‐induced hypertension, any serious bleeding episode in the current pregnancy, and/or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega‐3 could raise blood sugar and lower insulin promotion)
Setting: KLEUs Jawaharlal Nehru Medical College, Prabhakar Kore Charitable Hospital, Belgaum, Karnataka, India.
Interventions Intervention group
DHA (400 mg/day) from ≤ 20 weeks of gestation through 6 months postpartum
Control group
Placebo (400 mg/day corn/soy oil) from ≤ 20 weeks of gestation through 6 months postpartum
Outcomes Primary outcomes: infant neurodevelopment defined as measured by the mean difference in the average Developmental Quotient (DQ) scores of the 2 groups
Other outcomes: DHA levels (fatty acid levels in maternal and infant blood)
Starting date December 2015
Contact information Public Health Foundation of India cited as responsible party, no further details.
Notes Funding and collaborators: Public Health Foundation of India, Jawaharlal Nehru Medical College, India Alliance
Estimated study completion date: December 2020 (primary completion August 2019)