Pediatric ObesityNCT02236208
Effect of Folate Acid on Offspring Obesity
An observational study of Pediatric Obesity, run by Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to observe the effect of lack or excess of folic acid in first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pediatric Obesity
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2015
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Women with the early, mid and late pregnancy; Chilren
Who may be able to join
- Pregnancy women
- children
- Chinese
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210004
About this study
Official title: Mechanism of Folate Acid in Influencing Offspring Obesity During Pregnancy
The purpose of this study is to observe the effect of lack or excess of folic acid in first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.
- Conditions
- Pediatric Obesity
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of folate acid of pregnancy women at first trimester
Measured: 12 weeks of pregnancy
Secondary outcomes (7)
The level of folate acid of pregnancy women at second trimester
Measured: 20-24 weeks of pregnancy
The level of folate acid of pregnancy women at third trimester
Measured: 28-40 weeks of pregnancy
The birth weight, fat content and metabolism related hormone secretion of their offspring
Measured: At birth
The weight, fat content and metabolism related hormone secretion of their offspring at one year old
Measured: One years old
The weight, fat content and metabolism related hormone secretion of their offspring at 3 years old
Measured: 3 years old
The weight, fat content and metabolism related hormone secretion of their offspring at 5-7 years old
Measured: 5-7 years old
The weight, fat content and the secretion of metabolism related hormone of offspring at 18 years old
Measured: 18 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xirong Guo, Nanjing Medical University
- Investigators
- Xirong Guo, Dr., Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236208
- Sponsor's protocol ID
- NMU-530604-XG1
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Folate Acid in Influencing Offspring Obesity During Pregnancy
- ClinicalTrials.gov ID
- NCT02236208
- Acronym / sponsor ID
- NMU-530604-XG1
- Conditions
- Pediatric Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 10 Sep 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.
The purpose of this study is to observe the effect of lack or excess of folic acid in first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with the early, mid and late pregnancy; Chilren
Key inclusion criteria (3 listed)
- Pregnancy women
- children
- Chinese
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The level of folate acid of pregnancy women at first trimester
Time frame: 12 weeks of pregnancy
7 secondary outcomes
The level of folate acid of pregnancy women at second trimester
Time frame: 20-24 weeks of pregnancy
The level of folate acid of pregnancy women at third trimester
Time frame: 28-40 weeks of pregnancy
The birth weight, fat content and metabolism related hormone secretion of their offspring
Time frame: At birth
The weight, fat content and metabolism related hormone secretion of their offspring at one year old
Time frame: One years old
The weight, fat content and metabolism related hormone secretion of their offspring at 3 years old
Time frame: 3 years old
The weight, fat content and metabolism related hormone secretion of their offspring at 5-7 years old
Time frame: 5-7 years old
The weight, fat content and the secretion of metabolism related hormone of offspring at 18 years old
Time frame: 18 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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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.
Xirong Guo, Dr. principal investigator
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, run by Nanjing Medical University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Sep 2014. 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 China. 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?
Results are not available in the source record.
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?
The level of folate acid of pregnancy women at first trimester (time frame: 12 weeks of pregnancy). 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 11 Sep 2014.