1. The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol
- Author
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Dorairaj Prabhakaran, K. Srinath Reddy, M. K. Swamy, Dimple Kondal, Bhalchandra S. Kodkany, Lakshmy Ramakrishnan, Shweta Khandelwal, Ruby Gupta, Kamal Patil, Mahesh Kamate, Monica Chaudhry, Mrutyunjaya B Bellad, Usha Ramakrishnan, Gauri Divan, Reynaldo Martorell, Nikhil Tandon, Aryeh D. Stein, and Anita Gan
- Subjects
Neurodevelopment ,Placebo-controlled study ,Physiology ,n3PUFA ,Maternal supplementation ,Study Protocol ,0302 clinical medicine ,Child Development ,Pregnancy ,Docosahexaenoic acid (DHA) ,Medicine ,030212 general & internal medicine ,2. Zero hunger ,Anthropometry ,lcsh:RJ1-570 ,food and beverages ,Gestational age ,Newborn outcomes ,Prenatal Care ,3. Good health ,Breast Feeding ,Docosahexaenoic acid ,Research Design ,Gestation ,Female ,Adult ,Adolescent ,Docosahexaenoic Acids ,Offspring ,India ,Placebo ,03 medical and health sciences ,Young Adult ,Double-Blind Method ,Fatty Acids, Omega-3 ,Humans ,Lactation ,Pregnancy outcomes ,Milk, Human ,business.industry ,Infant, Newborn ,Infant ,lcsh:Pediatrics ,medicine.disease ,Development assessment scale for Indian infants (DASII) ,Neurodevelopmental Disorders ,Pediatrics, Perinatology and Child Health ,Dietary Supplements ,Polyunsaturated fatty acids ,business ,030217 neurology & neurosurgery ,Omega 3 fatty acids - Abstract
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. 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. 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. The trial is retrospectively registered at clinicaltrials.gov ( NCT01580345 , NCT03072277 ) and ctri.nic.in ( CTRI/2013/04/003540 , CTRI/2017/08/009296 ).
- Published
- 2018