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Randomized Controlled Trial
. 2020 Oct 3;12(10):3041.
doi: 10.3390/nu12103041.

Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial

Shweta Khandelwal  1   2 , Dimple Kondal  1   2 , Monica Chaudhry  1 , Kamal Patil  3 , Mallaiah Kenchaveeraiah Swamy  3 , Deepa Metgud  4 , Sandesh Jogalekar  3 , Mahesh Kamate  3 , Gauri Divan  5   6 , Ruby Gupta  1   2 , Dorairaj Prabhakaran  1   2 , Nikhil Tandon  7 , Usha Ramakrishnan  8 , Aryeh D Stein  8
Affiliations
Randomized Controlled Trial

Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial

Shweta Khandelwal et al. Nutrients. .

Abstract

Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.

Keywords: India; docosahexaenoic acid (DHA); lactation; maternal supplementation; neurodevelopment; pregnancy; randomized controlled trial (RCT).

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Consort. # Reasons for exclusion: gestational diabetes (n = 69); Hb < 7 gm% (n = 46); gestational age >20 weeks (n = 673); high-risk pregnancies (n = 118); chronic conditions (n = 246); under any other trial (n = 4); delivery plan other than PK (n = 835); missing/wrong contact information (n = 257). * Others included: abortion (n = 1); abruptio placenta (n = 1); fresh stillbirth (n = 4); macerated stillbirth (n = 3); neonatal death (n = 2); maternal death (n = 1); congenital anomalies (n = 1); infant death (n = 2) in DHA group. ** Others included: fresh stillbirth (n = 4); macerated stillbirth (n = 2); medical termination (n = 1) in Placebo group.
Figure 2
Figure 2
Subgroup analysis. Difference: Placebo minus DHA; Difference in mean DQ score between DHA and placebo group at 12 months was calculated using two-sample t-test for each subgroup; p-value for interaction calculated using linear regression model including interaction term for characteristic of interest and treatment group.
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