MedTrace Logo

Developmental Origins of Mental Health Disorders

NCT03096028 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 386

Last updated 2025-02-21

No results posted yet for this study

Summary

Common mental disorders (CMD) such as Depression, contributes significantly to the global burden of disease. Fetal exposure to adverse intrauterine environment mediated by life course factors can enhance risk of non-communicable disease in later life. Maternal micronutrients such as Vitamin B12 and folate play an important role in early fetal development through their effect on one carbon metabolism.

Vitamin B12 deficiency is common in Indian women; however guidelines recommend only iron, folic acid supplementation during pregnancy. This study aims to investigate effects of maternal B12, folate during pregnancy on mental health and neurocognitive outcomes in offspring during adulthood.

The Pune Maternal Nutrition Study(PMNS) birth-cohort(n=762) was established in 1993 at the Diabetes Unit of KEM Hospital Pune with well characterized serial data and archived biological samples. The subjects of the cohort are now in age range of 20-22 years and this provides an opportunity to examine the proposed objectives.

Key objectives:

To examine the specific association between maternal vitaminB12, folate, homocysteine levels at 18 \& 28 weeks of gestation and risk for CMD, neurocognitive outcomes.

Examine the causality of this association by Mendelian randomisation using genetic determinants of vitamin B12 and homocysteine.

Design and analysis:

Consenting members of the birth cohort of PMNS (n=690) will be recruited after ethics approval.

Following cross-sectional outcome measures will be measured Neurocognitive functions: using standardized neuropsychological battery Brain imaging for Structural and functional magnetic resonance imaging (MRI). Temperament-character dimensions (TCI):140 item short TCI-R. Structured clinical interview for CMD, Diet, physical activity, High-risk behaviors, Early life stress.

Serum Brain Derived Neurotrophic factor (BDNF), Insulin like growth factor (IGF-1) from serum archived at 6,12 \& 18 years.

Longitudinal methods and multivariate regression analysis would be used to investigate the hypothesized associations. Path analysis will be used to generate pathways of evolution of the abnormalities.

Causality of the associations will be assessed by Mendelian randomization analysis (triangulation and instrumental variable analysis) using maternal genetic determinants of vitamin B12 and homocysteine

Conditions

  • Neurodevelopmental Disorders

Interventions

OTHER

maternal vitamin B12 folate level during pregnancy

Maternal Vitamin B12 and folate level at 18\&28 weeks of pregnancy is the primary exposure of interest

Sponsors & Collaborators

  • Kem Hospital, Pune, India

    lead OTHER

Principal Investigators

  • Rishikesh V Behere, MD · Wellcome trust/DBT India Alliance Intermediate Fellow

Eligibility

Min Age
20 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2020-02-20
Completion
2020-02-20

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096028 on ClinicalTrials.gov