- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841813
Effects of Genomic and Metabolomic Variations of Choline on Risk of Preterm Birth and Clinical Outcomes in Preterms
July 26, 2016 updated by: Jie Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Genomic and Metabolomic Differences of Choline on the Risk of Preterm Delivery and Their Effects on Clinical Outcomes in Preterms Receiving Total Parenteral Nutrition Therapy
The incidence of preterm birth increases annually.
Premature delivery has become the leading cause of neonatal illness and death.
For the survived premature babies, the incidence of sequelae is also higher than the full-term babies, which brings a heavy burden to a family and society.
Preterm birth has become the important factor affecting the quality of births.
The occurrence of premature birth is the outcome of combined action of genetic and environmental factors.
However, its etiology is not clear.
Recent studies have shown that the risk of preterm birth is associated with dietary factors.
Choline is an essential nutrient for human health and it plays an important role in the growth and development of fetuses and neonates.
The investigators previously found that serum levels of free choline in preterm mothers were lower than those in normal mothers with full-term birth.
Serum levels of free choline also reduced in preterms after receiving parenteral nutrition (PN).
However, the relationships between choline and preterm birth is not clear.
Therefore, this study is aimed to explore the effect of choline intake during pregnancy and genetic polymorphisms on the risk of preterm birth and on the clinical outcomes in preterms receiving total PN therapy.
Healthy Chinese pregnant women with their healthy term infants will be recruited as the control group, while Chinese women with preterm delivery and their preterm infants will be recruited as the preterm group.
Dietary choline intake during pregnancy will be evaluated by semi-quantitative food frequency questionnaire and 24-h dietary recall questionnaire.
Gene polymorphisms in the key enzymes of choline metabolism will be identified among the participated women and neonates through Real-time polymerase chain reaction.
Choline and its related metabolites will be assayed using high performance liquid chromatography combined with mass spectrometry among all mothers and preterms before and after 7-days PN treatment.
The influence of genetic risk factors and metabolic changes of choline on the physical and mental development of preterms will be evaluated.
The results of this study will contribute to a comprehensive understanding of the role of choline and the relative gene polymorphisms on the risk of preterm birth, which will be helpful for estimating the high risk in advance.
The results will also provide the scientific evidences to establish the personalized amount of choline intake among women and infants, optimize nutrition support for pregnant women and preterms, and promote better prenatal and postnatal care.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Zhu, MD,PhD
- Phone Number: 648 86-021-2507-8999
- Email: jacky284868@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200092
- Recruiting
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
-
Contact:
- Jie Zhu, MD, PhD
- Phone Number: 6418 86-021-2507-8999
- Email: jacky284868@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy Chinese women with their healthy term infants were recruited as the control group, while Chinese women with preterm delivery and their preterm infants (gestational age < 37w) were recruited as the preterm group.
Description
Inclusion Criteria:
- Preterm group: preterm infants (gestational age < 37 w) and their mothers (125 pairs );
- Control group: healthy full-term infants and their mothers (125 pairs );_
- Admission to Xin Hua Hospital, Shanghai;_ 4.1600g ≤ birth weight ≤ 2100g for preterms;
5.Administration of total parenteral nutrition (TPN) ≥ 7d; 6.No contraindication of TPN therapy.
Exclusion Criteria:
- Administration of TPN before enrollment;
- Receive blood infusion during TPN treatment;
- Liver or renal markers present at 2 times higher than the normal level;
- Suspected or identified chromosome diseases, congenital metabolic disease, congenital digestive tract diseases and necrotizing enterocolitis;
- Cytomegalovirus infection, viral hepatitis, and congenital or acquired immune deficiency.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
The normal mothers group
No intervention
|
No intervention
|
The normal full-term infants group
No intervention
|
No intervention
|
The preterm mothers group
No intervention
|
No intervention
|
The preterms group
No intervention
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distribution of single nucleotide polymorphisms of the targeted genes
Time Frame: June 2016 - December,2019
|
June 2016 - December,2019
|
Plasma concentrations of choline
Time Frame: 3 years
|
3 years
|
Plasma concentrations of betaine
Time Frame: 3 years
|
3 years
|
Plasma concentrations of phosphocholine
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dietary questionnaire of choline intake during pregnancy
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Serum alanine aminotransferase
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Serum aspartate aminotransferase
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Serum total bilirubin
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Serum direct bilirubin
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Serum bile acid
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Serum gamma glutamyl transferase
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Serum triglyceride
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Mental developmental index
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Psychomotor developmental index
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jie Zhu, MD,PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
July 19, 2016
First Posted (Estimate)
July 22, 2016
Study Record Updates
Last Update Posted (Estimate)
July 27, 2016
Last Update Submitted That Met QC Criteria
July 26, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-16-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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