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Developmental Origins of Mental Health Disorders

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ClinicalTrials.gov Identifier: NCT03096028
Recruitment Status : Not yet recruiting
First Posted : March 30, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Rishikesh V Behere, Kem Hospital, Pune, India

Brief 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


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
Observational Model: Cohort
Time Perspective: Cross-Sectional
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


Group/Cohort Intervention/treatment
PMNS cohort
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   20 Years to 23 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
700 male and female adult members of the Pune Maternal Nutrition Study birth cohort
Criteria

Inclusion Criteria:

  • male or female adult member of the PMNS cohort
  • Availability of data on maternal vitamin B12 and folate levels during 18&28 weeks of pregnancy for the subject
  • Subject should have completed longitudinal assessments at 6, 12 and 18 years of age

Exclusion Criteria:

  • Pregnancy
  • Contraindications for MRI such as metallic orthopedic or dental implants, claustrophobia.

Information from the National Library of Medicine

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


Contacts
Contact: Rishikesh V Behere, MD 0091-20-26061958 rvbehere@gmail.com
Contact: Chittaranjan Yajnik, MD 0091-20-26061958 diabetes@kemdiabetes.org

Locations
India
KEM Hospital Research Center Not yet recruiting
Pune, Maharashtra, India, 411011
Contact: Laila Garda, MD    00-91-20-66037336    research@kemhrcpune.org   
Contact: Chittaranjan Yajnik, MD    00-91-20-26061958    diabetes@kemdiabetes.org   
Principal Investigator: Rishikesh V Behere, MD         
Sponsors and Collaborators
Kem Hospital, Pune, India
Investigators
Principal Investigator: Rishikesh V Behere, MD Wellcome trust/DBT India Alliance Intermediate Fellow

Additional Information:
Responsible Party: Dr Rishikesh V Behere, Principal Investigator, Kem Hospital, Pune, India
ClinicalTrials.gov Identifier: NCT03096028     History of Changes
Other Study ID Numbers: kemhrc/adhoc27
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Rishikesh V Behere, Kem Hospital, Pune, India:
maternal nutrition
neurocognitive development
brain volume

Additional relevant MeSH terms:
Disease
Neurodevelopmental Disorders
Mental Disorders
Pathologic Processes
Vitamins
Vitamin B 12
Hydroxocobalamin
Folic Acid
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics