Developmental Origins of Neurocognitive and Behavioral Endophenotypes and Common Mental Health Disorders in Young Adults of a Prospective Birth Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Prevalence of common mental disorders in members of the PMNS cohort Assessed on Mini Neuropsychiatric interview 6.0
研究概览
简要总结
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
详细描述
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.
Primary objectives:
To examine the specific association between maternal vitaminB12, folate, homocysteine levels(independently and in interaction with each other) at 18 & 28 weeks of gestation and neurocognitive outcomes and risk for CMD at around 21 years of age, controlling for effect of other nutrients (calorie, protein and fat intake, and levels of vitamin C,D, ferritin).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnancy
- •Contraindications for MRI such as metallic orthopedic or dental implants, claustrophobia.
结局指标
主要结局
Prevalence of common mental disorders in members of the PMNS cohort Assessed on Mini Neuropsychiatric interview 6.0
时间窗: outcome assessed at 22 years from primary exposure
Odds ratios for prevalence of common mental disorders will be computed
次要结局
- Neurocognitive functioning as assessed by performance on a standardized neuropsychological test battery(outcome assessed at 22 years from primary exposure)
- Brain volumes on structural and functional connectivity using resting stated Magnetic resonance imaging(outcome assessed at 22 years from primary exposure)
- Temperament and character dimensions as assessed on the Temperament and character inventory - R 140(outcome assessed at 22 years from primary exposure)
研究者
Dr Rishikesh V Behere
Principal Investigator
Kem Hospital, Pune, India