Off-spring Cancer RiskNCT02266641
Parental One-carbon Folate and Choline Nutrition Modulates Risk of Off-spring Cancer Development: Human Cohort Study
A study testing nutrition counseling and multivitamin supplement in people with Off-spring Cancer Risk, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms of one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome molecule, to promote the individual nutrient… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Off-spring Cancer Risk
- What is being tested?
- nutrition counseling and multivitamin supplement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women aged 21-40 years with first and single fetal pregnancy
- Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had diabetes
- Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had cancer
- 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.
Who cannot join
- Pregnant women who had heart disease, kidney disease, cancer or accepting medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms of one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome molecule, to promote the individual nutrient growth factor of growth and development. Inadequate maternal one-carbon nutrient intake combined with genetic polymorphisms of one-carbon enzymatic mutation, causing one-carbon malnutrition, change fetal methyl metabolic nutrition environment. It not only leads to fetal growth mutation - such as folate and choline deficiency, increasing the risk of fetal neural tube defect but also induce abnormal modifying of fetuses's post-genomic methylation markers, may alter imprinted genes function of progenitors, recompile threshold sensitivity or domain in regulation of metabolic reactions of offspring, resulting in long-lasting effect, increasing the risk of chronic diseases of offspring such as cancer. According to the National Nutrition Survey results show that a considerable proportion of the Taiwanese people had poor one-carbon nutritional status. 48% of women intake 66% below the recommended intake reference value of folate. Whether inadequate parental one-carbon nutrients intake combined with genetic polymorphisms of one-carbon enzymatic mutation will cause one-carbon malnutrition of fetus, affecting fetal growth and modifying the risk of cancer development relationship of offspring. It is due to the lack of local ethnic data and empirical scientific reference at home and abroad, so it can not plan an effective maternal and children nutrient education and prevention strategies about methyl nutrition for early cancer prevention for Taiwanese. Therefore, indigenous people is the intended population of study in this project, screening of healthy pregnant women with high risk factor for cancer and obese pregnant women, and detection of one-carbon nutrient intake and biochemical assessment of the nutritional status of the study group. Supplying nutrition education intervention or multivitamin supplement to improve the poor nutritional status of persons. Using related DNA methylation imprint marker about offspring growth and modifying development of cancer as assessment, this project explores the appropriate one-carbon nutrient intake in parents and children and the assessments in regulation of growth and reducing the cancer-related risk.
- Conditions
- Off-spring Cancer Risk
- Being tested
- nutrition counseling, multivitamin supplement
- Keywords
- one-carbon metabolism, folate, choline, DNA methylation, imprint marker, cancer risks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition counselingBehavioural
Pregnancy diet (include one-carbon nutrients)
multivitamin supplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnant women | Active comparator | Supply nutrition counseling and multivitamin supplement to people with poor nutritional status Receives: Behavioral: nutrition counseling; Dietary Supplement: multivitamin supplement |
| healthy pregnant women's lineal relative with cancer | Experimental | Supply nutrition counseling and multivitamin supplement to people with poor nutritional status Receives: Behavioral: nutrition counseling; Dietary Supplement: multivitamin supplement |
| pregnant women or lineal relative with overweight/obesity | Experimental | Supply nutrition counseling and multivitamin supplement to people with poor nutritional status Receives: Behavioral: nutrition counseling; Dietary Supplement: multivitamin supplement |
| healthy pregnant women's lineal relative with diabetes | No intervention | Supply nutrition counseling and multivitamin supplement to people with poor nutritional status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the first trimester visit of pregnancy
Using semiquantitative food frequency questionnaires (FFQ) to calculate dietary intake of one-carbon nutrient
Measured: 7-10 weeks
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the second trimester of pregnancy
Using 24 hours dietary recall and dietary record to calculate dietary intake of one-carbon nutrient
Measured: 20-28 weeks
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the third trimester of pregnancy
Using 24 hours dietary recall and dietary record to calculate dietary intake of one-carbon nutrient
Measured: 36-37 weeks
Secondary outcomes (7)
Measure maternal blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
Measured: 7-10 weeks
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-α, NF-κB, Interleukin, etc.)
Measured: 7-10 weeks
Measure maternal blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
Measured: 24-28 weeks
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-α, NF-κB, Interleukin, etc.)
Measured: 24-28 weeks
Measure maternal blood, cord blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
Measured: 37-40 weeks
Measure maternal and cord blood and placenta tissues MTHFR C677T genotypes
Measured: 37-40 weeks
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-α, NF-κB, Interleukin, etc.)
Measured: 37-40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Off-spring Cancer RiskStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Nan Lee, Principal investigator, National Taiwan University HospitalKuang-Ta Huang, Principal investigator, Hueishin women and children clinicChin-Pao Cheng, Principal investigator, National Taiwan University HospitalRwei-Fen S. Huang, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266641
- Sponsor's protocol ID
- 201401034RINB
- Status last verified
- May 2017
- First submitted
- 13 Oct 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental One-carbon Folate and Choline Nutrition Modulates Risk of Off-spring Cancer Development: Human Cohort Study
- ClinicalTrials.gov ID
- NCT02266641
- Acronym / sponsor ID
- 201401034RINB
- Conditions
- Off-spring Cancer Risk
- Keywords
- one-carbon metabolism, folate, choline, DNA methylation, imprint marker, cancer risks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms of one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome molecule, to promote the individual nutrient growth factor of growth and development. Inadequate maternal one-carbon nutrient intake combined with genetic polymorphisms of one-carbon enzymatic mutation, causing one-carbon malnutrition, change fetal methyl metabolic nutrition environment. It not only leads to fetal growth mutation - such as folate and choline deficiency, increasing the risk of fetal neural tube defect but also induce abnormal modifying of fetuses's post-genomic methylation markers, may alter imprinted genes function of progenitors, recompile threshold sensitivity or domain in regulation of metabolic reactions of offspring, resulting in long-lasting effect, increasing the risk of chronic diseases of offspring such as cancer. According to the National Nutrition Survey results show that a considerable proportion of the Taiwanese people had poor one-carbon nutritional status. 48% of women intake 66% below the recommended intake reference value of folate. Whether inadequate parental one-carbon nutrients intake combined with genetic polymorphisms of one-carbon enzymatic mutation will cause one-carbon malnutrition of fetus, affecting fetal growth and modifying the risk of cancer development relationship of offspring. It is due to the lack of local ethnic data and empirical scientific reference at home and abroad, so it can not plan an effective maternal and children nutrient education and prevention strategies about methyl nutrition for early cancer prevention for Taiwanese. Therefore, indigenous people is the intended population of study in this project, screening of healthy pregnant women with high risk factor for cancer and obese pregnant women, and detection of one-carbon nutrient intake and biochemical assessment of the nutritional status of the study group. Supplying nutrition education intervention or multivitamin supplement to improve the poor nutritional status of persons. Using related DNA methylation imprint marker about offspring growth and modifying development of cancer as assessment, this project explores the appropriate one-carbon nutrient intake in parents and children and the assessments in regulation of growth and reducing the cancer-related risk.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant women | Active comparator | Behavioral: nutrition counseling, Dietary Supplement: multivitamin supplementSupply nutrition counseling and multivitamin supplement to people with poor nutritional status |
| healthy pregnant women's lineal relative with cancer | Experimental | Behavioral: nutrition counseling, Dietary Supplement: multivitamin supplementSupply nutrition counseling and multivitamin supplement to people with poor nutritional status |
| pregnant women or lineal relative with overweight/obesity | Experimental | Behavioral: nutrition counseling, Dietary Supplement: multivitamin supplementSupply nutrition counseling and multivitamin supplement to people with poor nutritional status |
| healthy pregnant women's lineal relative with diabetes | No intervention | –Supply nutrition counseling and multivitamin supplement to people with poor nutritional status |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnant women aged 21-40 years with first and single fetal pregnancy
- Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had diabetes
- Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had cancer
- 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.
Key exclusion criteria (1 listed)
- Pregnant women who had heart disease, kidney disease, cancer or accepting medical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition counselingPregnancy diet (include one-carbon nutrients) | Behavioural | healthy pregnant women, healthy pregnant women's lineal relative with cancer, pregnant women or lineal relative with overweight/obesity |
| multivitamin supplement | Dietary supplement | healthy pregnant women, healthy pregnant women's lineal relative with cancer, pregnant women or lineal relative with overweight/obesity |
Primary outcome
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the first trimester visit of pregnancy
Time frame: 7-10 weeks
Using semiquantitative food frequency questionnaires (FFQ) to calculate dietary intake of one-carbon nutrient
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the second trimester of pregnancy
Time frame: 20-28 weeks
Using 24 hours dietary recall and dietary record to calculate dietary intake of one-carbon nutrient
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the third trimester of pregnancy
Time frame: 36-37 weeks
Using 24 hours dietary recall and dietary record to calculate dietary intake of one-carbon nutrient
7 secondary outcomes
Measure maternal blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
Time frame: 7-10 weeks
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-α, NF-κB, Interleukin, etc.)
Time frame: 7-10 weeks
Measure maternal blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
Time frame: 24-28 weeks
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-α, NF-κB, Interleukin, etc.)
Time frame: 24-28 weeks
Measure maternal blood, cord blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
Time frame: 37-40 weeks
Measure maternal and cord blood and placenta tissues MTHFR C677T genotypes
Time frame: 37-40 weeks
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-α, NF-κB, Interleukin, etc.)
Time frame: 37-40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Nan Lee principal investigator
National Taiwan University Hospital
Kuang-Ta Huang principal investigator
Hueishin women and children clinic
Chin-Pao Cheng principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition counseling and multivitamin supplement in people with Off-spring Cancer Risk, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the first trimester visit of pregnancy (time frame: 7-10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.