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. 2018 Aug 4;18(1):261.
doi: 10.1186/s12887-018-1225-5.

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

Shweta Khandelwal  1   2 , M K Swamy  3 , Kamal Patil  3 , Dimple Kondal  4 , Monica Chaudhry  4 , Ruby Gupta  4 , Gauri Divan  5 , Mahesh Kamate  6 , Lakshmy Ramakrishnan  7 , Mrutyunjaya B Bellad  3 , Anita Gan  3 , Bhalchandra S Kodkany  8 , Reynaldo Martorell  9 , K Srinath Reddy  4 , Dorairaj Prabhakaran  4   10 , Usha Ramakrishnan  9 , Nikhil Tandon  7 , Aryeh D Stein  9
Affiliations

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

Shweta Khandelwal et al. BMC Pediatr. .

Abstract

Background: Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns.

Methods: DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18-35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant's socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression.

Discussion: Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country.

Trial registration: The trial is retrospectively registered at clinicaltrials.gov ( NCT01580345 , NCT03072277 ) and ctri.nic.in ( CTRI/2013/04/003540 , CTRI/2017/08/009296 ).

Keywords: Development assessment scale for Indian infants (DASII); Docosahexaenoic acid (DHA); Maternal supplementation; Neurodevelopment; Newborn outcomes; Omega 3 fatty acids; Polyunsaturated fatty acids; Pregnancy outcomes; n3PUFA.

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Conflict of interest statement

Ethical clearances were obtained from all participating institutions including: Chronic Disease Control (CCDC-IEC_04_2015), Public Health Foundation of India (TRC-IEC-261/15), Jawaharlal Nehru Medical College (MDC/IECHSR/2016–17/A-85) and All India Institute of Medical Sciences (IEC-28/17.11.2015). Written informed consent was obtained from each willing and eligible participant in presence of her close relative or friend.

Not Applicable.

The authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT Diagram
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