Developmental Origins of Mental Health Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03096028|
Recruitment Status : Not yet recruiting
First Posted : March 30, 2017
Last Update Posted : August 21, 2017
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.
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
|Condition or disease||Intervention/treatment|
|Neurodevelopmental Disorders||Other: maternal vitamin B12 folate level during pregnancy|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Developmental Origins of Neurocognitive and Behavioral Endophenotypes and Common Mental Health Disorders in Young Adults of a Prospective Birth Cohort|
|Estimated Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||February 28, 2022|
The Pune Maternal Nutrition Study (PMNS) is a preconceptional birth cohort established in 1993 at Diabetes unit KEM hospital research center, Pune. 700 offsprings of the cohort are being followed every 6 years. Maternal vitamin B12 folate level during pregnancy were measured at 18 & 28 weeks.
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
- Prevalence of common mental disorders in members of the PMNS cohort Assessed on Mini Neuropsychiatric interview 6.0 [ Time Frame: outcome assessed at 22 years from primary exposure ]Odds ratios for prevalence of common mental disorders will be computed
- Neurocognitive functioning as assessed by performance on a standardized neuropsychological test battery [ Time Frame: outcome assessed at 22 years from primary exposure ]composite z score obtained from performance on a standardized neuropsychological battery
- Temperament and character dimensions as assessed on the Temperament and character inventory - R 140 [ Time Frame: outcome assessed at 22 years from primary exposure ]Mean scores on the different dimension of temperament and characters as assessed on TCI - 140 R
- Brain volumes on structural and functional connectivity using resting stated Magnetic resonance imaging [ Time Frame: outcome assessed at 22 years from primary exposure ]Total and regional gray matter volumes differences in relation to the exposures on voxel based morphometry. Functional connectivity analysis using Blood oxygen level dependent differences between hippocampus and dorsolateral prefrontal cortex
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096028
|Contact: Rishikesh V Behere, MDemail@example.com|
|Contact: Chittaranjan Yajnik, MDfirstname.lastname@example.org|
|KEM Hospital Research Center||Not yet recruiting|
|Pune, Maharashtra, India, 411011|
|Contact: Laila Garda, MD 00-91-20-66037336 email@example.com|
|Contact: Chittaranjan Yajnik, MD 00-91-20-26061958 firstname.lastname@example.org|
|Principal Investigator: Rishikesh V Behere, MD|
|Principal Investigator:||Rishikesh V Behere, MD||Wellcome trust/DBT India Alliance Intermediate Fellow|