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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02266641 |
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Date of registration:
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13/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Parental One-carbon Folate and Choline Nutrition Modulates Risk of Off-spring Cancer Development: Human Cohort Study
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Scientific title:
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Parental One-carbon Folate and Choline Nutrition Modulates Risk of Off-spring Cancer Development: Human Cohort Study |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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118 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02266641 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Rwei-Fen S. Huang |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fu Jen Catholic University |
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Name:
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Kuang-Ta Huang |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hueishin women and children clinic |
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Name:
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Chien-Nan Lee |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Name:
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Chin-Pao Cheng |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Healthy pregnant women aged 21-40 years with first and single fetal pregnancy
2. Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and
lineal relative had diabetes
3. Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and
lineal relative had cancer
4. Healthy pregnant women, who are overweight/obesity (pre-pregnancy BMI?24 kg/m2) or her
lineal relative with overweight/obesity, aged 21-40 years with first and single fetal
pregnancy.
Exclusion Criteria:
- Pregnant women who had heart disease, kidney disease, cancer or accepting medical
treatment
Age minimum:
21 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Off-spring Cancer Risk
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Intervention(s)
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Behavioral: nutrition counseling
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Dietary Supplement: multivitamin supplement
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Primary Outcome(s)
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Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the first trimester visit of pregnancy
[Time Frame: 7-10 weeks]
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Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the second trimester of pregnancy
[Time Frame: 20-28 weeks]
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Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the third trimester of pregnancy
[Time Frame: 36-37 weeks]
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Secondary Outcome(s)
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Measure maternal blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
[Time Frame: 24-28 weeks]
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Measure maternal and cord blood and placenta tissues MTHFR C677T genotypes
[Time Frame: 37-40 weeks]
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Measure maternal blood imprinted genes (sonic hedgehog, insulin-like growth factor 2, long interspersed nuclear element 1, etc.) DNA methylation status, DNA 8-Hydroxydeoxyguanosine (8-OHdG) and inflammatory markers (TNF-a, NF-?B, Interleukin, etc.)
[Time Frame: 7-10 weeks]
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Measure maternal blood, cord blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
[Time Frame: 37-40 weeks]
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Measure maternal blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
[Time Frame: 7-10 weeks]
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Measure maternal blood imprinted genes (sonic hedgehog, insulin-like growth factor 2, long interspersed nuclear element 1, etc.) DNA methylation status, DNA 8-Hydroxydeoxyguanosine (8-OHdG) and inflammatory markers (TNF-a, NF-?B, Interleukin, etc.)
[Time Frame: 37-40 weeks]
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Measure maternal blood imprinted genes (sonic hedgehog, insulin-like growth factor 2, long interspersed nuclear element 1, etc.) DNA methylation status, DNA 8-Hydroxydeoxyguanosine and inflammatory markers (TNF-a, NF-?B, Interleukin, etc.)
[Time Frame: 24-28 weeks]
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Secondary ID(s)
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201401034RINB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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