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The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol
- Source :
- BMC Pediatrics, Vol 18, Iss 1, Pp 1-11 (2018), BMC Pediatrics
- Publication Year :
- 2018
- Publisher :
- BMC, 2018.
-
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 ).
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 14712431 and 01580345
- Volume :
- 18
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMC Pediatrics
- Accession number :
- edsair.doi.dedup.....59c1e726c7e0b8dd24f7cfc89f27d632