Study to understand the effect of new micronutrients to improve pregnancy and child outcomes in pregnant women

A randomized control trial to understand the effect of novel nutrients for maternal, newborn, and child health in the rural community in India

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080790

Enrollment

1800

Registered

2025-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Antenatal supplementation with novel micronutrients - nicotinamide, choline, and DHA (Docosohexanoic acid): Intervention will have standard care (Iron and folic acid, calcium supplemen

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women with confirmed pregnancy with gestational age less than 14 weeks 2. Living in the recruitment geographical area and willing to spend the whole pregnancy in the area for the main study and 2-year postpartum for the sub-study 3. Singleton and viable fetus on ultrasound

Exclusion criteria

Exclusion criteria: 1) Pregnant women with any known medical co-morbidities in the pre-pregnancy period (DM, HTN, Thyroid, SLE, etc) 2) Multipara with bad obstetric history 3) Any known food allergies

Design outcomes

Primary

Measure	Time frame
Primary outcomes 1. Effect on newborn outcomes - compound and individual outcomes (% low birth weight, % preterm, % small for gestation age, neonatal mortality, neonatal significant morbidity) 2. Effect on pregnancy outcomes - compound and individual pregnancy outcomes (loss, preterm, maternal morbidity, mortality) 3. Effect on birth weight 4. Childhood growth and developmentTimepoint: 1. Newborn outcomes - birth/newborn period 2. Pregnancy outcomes - pregnancy monthly follow-up, birth 3. Birth weight -birth 4. Child growth Monthly follow-ups till 24 months Child development -6,12,18 and 24 months Hyperfine neuroimaging - 6, 12 and 24 months	—

Measure

Time frame

Primary outcomes 1. Effect on newborn outcomes - compound and individual outcomes (% low birth weight, % preterm, % small for gestation age, neonatal mortality, neonatal significant morbidity) 2. Effect on pregnancy outcomes - compound and individual pregnancy outcomes (loss, preterm, maternal morbidity, mortality) 3. Effect on birth weight 4. Childhood growth and developmentTimepoint: 1. Newborn outcomes - birth/newborn period 2. Pregnancy outcomes - pregnancy monthly follow-up, birth 3. Birth weight -birth 4. Child growth Monthly follow-ups till 24 months Child development -6,12,18 and 24 months Hyperfine neuroimaging - 6, 12 and 24 months

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Secondary

Measure	Time frame
Secondary Outcome/s: 1. Relationship between biochemical micronutrient & anemia status with childhood growth, development & brain morphometry. 2. Prevalence of iron deficiency & micronutrient deficiency anemia in pregnancy & early childhood 3. Effect of novel nutrients in improving maternal anemia & early childhood anemia Timepoint: 1. Child growth measured monthly postpartum till 24 months. Child development -6,12,18 & 24 months Hyperfine neuroimaging - 6, 12 &24 months 2. Pregnancy anemia prevalence- at recruitment Childhood anemia - 6 months & 24 months post-partum 3. Effect of novel micronutrients on anemia mothers - post-partum blood test Children - 6 months & 24 months post-partum	—

Measure

Time frame

Secondary Outcome/s: 1. Relationship between biochemical micronutrient & anemia status with childhood growth, development & brain morphometry. 2. Prevalence of iron deficiency & micronutrient deficiency anemia in pregnancy & early childhood 3. Effect of novel nutrients in improving maternal anemia & early childhood anemia Timepoint: 1. Child growth measured monthly postpartum till 24 months. Child development -6,12,18 & 24 months Hyperfine neuroimaging - 6, 12 &24 months 2. Pregnancy anemia prevalence- at recruitment Childhood anemia - 6 months & 24 months post-partum 3. Effect of novel micronutrients on anemia mothers - post-partum blood test Children - 6 months & 24 months post-partum

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Countries

India

Contacts

Public ContactDr Beena Koshy

Christian Medical College, Vellore

beenakurien@cmcvellore.ac.in04162283260

Outcome results