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Effects of Genomic and Metabolomic Variations of Choline on Risk of Preterm Birth and Clinical Outcomes in Preterms

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ClinicalTrials.gov Identifier: NCT02841813
Recruitment Status : Unknown
Verified July 2016 by Jie Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : July 22, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Jie Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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. 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.

Condition or disease Intervention/treatment
Genomic and Metabolomic Variations Preterm Birth Total Parenteral Nutrition Other: No intervention

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
The normal mothers group
No intervention
Other: No intervention
No intervention

The normal full-term infants group
No intervention
Other: No intervention
No intervention

The preterm mothers group
No intervention
Other: No intervention
No intervention

The preterms group
No intervention
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Distribution of single nucleotide polymorphisms of the targeted genes [ Time Frame: June 2016 - December,2019 ]
  2. Plasma concentrations of choline [ Time Frame: 3 years ]
  3. Plasma concentrations of betaine [ Time Frame: 3 years ]
  4. Plasma concentrations of phosphocholine [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Dietary questionnaire of choline intake during pregnancy [ Time Frame: through study completion, an average of 3 years ]
  2. Serum alanine aminotransferase [ Time Frame: through study completion, an average of 3 years ]
  3. Serum aspartate aminotransferase [ Time Frame: through study completion, an average of 3 years ]
  4. Serum total bilirubin [ Time Frame: through study completion, an average of 3 years ]
  5. Serum direct bilirubin [ Time Frame: through study completion, an average of 3 years ]
  6. Serum bile acid [ Time Frame: through study completion, an average of 3 years ]
  7. Serum gamma glutamyl transferase [ Time Frame: through study completion, an average of 3 years ]
  8. Serum triglyceride [ Time Frame: through study completion, an average of 3 years ]
  9. Mental developmental index [ Time Frame: through study completion, an average of 3 years ]
  10. Psychomotor developmental index [ Time Frame: through study completion, an average of 3 years ]

Biospecimen Retention:   Samples With DNA
Blood samples


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  1. Preterm group: preterm infants (gestational age < 37 w) and their mothers (125 pairs );
  2. Control group: healthy full-term infants and their mothers (125 pairs );_
  3. 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:

  1. Administration of TPN before enrollment;
  2. Receive blood infusion during TPN treatment;
  3. Liver or renal markers present at 2 times higher than the normal level;
  4. Suspected or identified chromosome diseases, congenital metabolic disease, congenital digestive tract diseases and necrotizing enterocolitis;
  5. Cytomegalovirus infection, viral hepatitis, and congenital or acquired immune deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841813


Contacts
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Contact: Jie Zhu, MD,PhD 86-021-2507-8999 ext 648 jacky284868@163.com

Locations
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China, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Jie Zhu, MD, PhD    86-021-2507-8999 ext 6418    jacky284868@163.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Jie Zhu, MD,PhD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Jie Zhu, Assitant Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02841813    
Other Study ID Numbers: XH-16-005
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications