Genomic and Metabolomic VariationsNCT02841813
Effects of Genomic and Metabolomic Variations of Choline on Risk of Preterm Birth and Clinical Outcomes in Preterms
An observational study of Genomic and Metabolomic Variations and Preterm Birth, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Genomic and Metabolomic Variations, Preterm Birth, Total Parenteral Nutrition
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Jie Zhu, MD, PhD, 86-021-2507-8999 ext. 6418, jacky284868@163.com
About this study
Official title: 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.
- Being tested
- No intervention
- Medical subject headings
- Premature Birth, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| The normal mothers group | No intervention Receives: Other: No intervention | |
| The normal full-term infants group | No intervention Receives: Other: No intervention | |
| The preterm mothers group | No intervention Receives: Other: No intervention | |
| The preterms group | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of single nucleotide polymorphisms of the targeted genes
Measured: June 2016 - December,2019
Plasma concentrations of choline
Measured: 3 years
Plasma concentrations of betaine
Measured: 3 years
Plasma concentrations of phosphocholine
Measured: 3 years
Secondary outcomes (10)
Dietary questionnaire of choline intake during pregnancy
Measured: through study completion, an average of 3 years
Serum alanine aminotransferase
Measured: through study completion, an average of 3 years
Serum aspartate aminotransferase
Measured: through study completion, an average of 3 years
Serum total bilirubin
Measured: through study completion, an average of 3 years
Serum direct bilirubin
Measured: through study completion, an average of 3 years
Serum bile acid
Measured: through study completion, an average of 3 years
Serum gamma glutamyl transferase
Measured: through study completion, an average of 3 years
Serum triglyceride
Measured: through study completion, an average of 3 years
Mental developmental index
Measured: through study completion, an average of 3 years
Psychomotor developmental index
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genomic and Metabolomic VariationsStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jie Zhu, MD,PhD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841813
- Sponsor's protocol ID
- XH-16-005
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02841813
- Acronym / sponsor ID
- XH-16-005
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Jul 2016 (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 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The normal mothers group | – | Other: No interventionNo intervention |
| The normal full-term infants group | – | Other: No interventionNo intervention |
| The preterm mothers group | – | Other: No interventionNo intervention |
| The preterms group | – | Other: No interventionNo intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| No interventionNo intervention | Other | The normal full-term infants group, The normal mothers group, The preterm mothers group, The preterms group |
Primary outcome
Distribution of single nucleotide polymorphisms of the targeted genes
Time frame: June 2016 - December,2019
Plasma concentrations of choline
Time frame: 3 years
Plasma concentrations of betaine
Time frame: 3 years
Plasma concentrations of phosphocholine
Time frame: 3 years
10 secondary outcomes
Dietary questionnaire of choline intake during pregnancy
Time frame: through study completion, an average of 3 years
Serum alanine aminotransferase
Time frame: through study completion, an average of 3 years
Serum aspartate aminotransferase
Time frame: through study completion, an average of 3 years
Serum total bilirubin
Time frame: through study completion, an average of 3 years
Serum direct bilirubin
Time frame: through study completion, an average of 3 years
Serum bile acid
Time frame: through study completion, an average of 3 years
Serum gamma glutamyl transferase
Time frame: through study completion, an average of 3 years
Serum triglyceride
Time frame: through study completion, an average of 3 years
Mental developmental index
Time frame: through study completion, an average of 3 years
Psychomotor developmental index
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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.
Jie Zhu, MD,PhD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 Genomic and Metabolomic Variations and Preterm Birth, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 5 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 27 Jul 2016. 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?
Contact Jie Zhu, MD,PhD (86-021-2507-8999 ext. 648, jacky284868@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of single nucleotide polymorphisms of the targeted genes (time frame: June 2016 - December,2019). The study lists 4 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 27 Jul 2016.