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

Preterm Birth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02841813
• Other study ID #: XH-16-005
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2016
• Last updated: July 26, 2016
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: July 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Jie Zhu, MD,PhD
• Phone: 86-021-2507-8999
• Email: jacky284868[@]163.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Genomic and Metabolomic Variations
• Premature Birth
• Preterm Birth
• Total Parenteral Nutrition

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of single nucleotide polymorphisms of the targeted genes		June 2016 - December,2019	No
Primary	Plasma concentrations of choline		3 years	No
Primary	Plasma concentrations of betaine		3 years	No
Primary	Plasma concentrations of phosphocholine		3 years	No
Secondary	Dietary questionnaire of choline intake during pregnancy		through study completion, an average of 3 years	No
Secondary	Serum alanine aminotransferase		through study completion, an average of 3 years	No
Secondary	Serum aspartate aminotransferase		through study completion, an average of 3 years	No
Secondary	Serum total bilirubin		through study completion, an average of 3 years	No
Secondary	Serum direct bilirubin		through study completion, an average of 3 years	No
Secondary	Serum bile acid		through study completion, an average of 3 years	No
Secondary	Serum gamma glutamyl transferase		through study completion, an average of 3 years	No
Secondary	Serum triglyceride		through study completion, an average of 3 years	No
Secondary	Mental developmental index		through study completion, an average of 3 years	No
Secondary	Psychomotor developmental index		through study completion, an average of 3 years	No