Peri-conception Key Nutritional Factors and Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— PKNFCHD  

Official title:

Peri-conception Key Nutritional Factors and Primary Prevention of Congenital Heart Disease(CHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737644
• Other study ID #: GWIV24_v1
• Status: Completed
• Start date: March 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is a nested case-control study and the purpose is to describe the status of key nutrients(eg.folic acid and vitamins) supplementation among pregnant women in Shanghai, to find out the association between the level of serum key nutrients during peri-conceptional period and the incidence of congenital heart defects (CHD) in newborn, and to provide better preconception care.

Description:

Congenital heart defects (CHD) are among the most common major congenital anomalies with an incidence of about 8-12/1,000 live births worldwide. The mechanism of CHD is still unclear. Many studies indicated that the level of key nutrients (eg.folic acid and vitamins) during peri-conceptional period might affect the incidence of CHD, but the evidence is limited. The study aimed to explore the association between serum key nutrients during peri-conceptional period and the incidence of CHD in newborn. All couples attending pre-pregnancy physical examination from 11 districts (Minhang District, Huangpu District, Xuhui District, Changning District, Jingan District, Putuo District, Yangpu District, Jiading District, Pudong District，Songjiang District, Qingpu District) in Shanghai from March 2016, are recruited and their blood samples and questionnaires about the supplementation of key nutrients are collected. During the gestation, venous blood of pregnant women at all of three trimesters is taken. Besides, questionnaires about the supplementation of key nutrients at the first antenatal visit are also obtained. The level of serum folic acid, vitamin A and vitamin B12 at preconception and during gestation are measured. Finally, investigators identifies those whose newborns developed CHD during follow-up as the cases. Then, investigators selects four controls for each case from the rest of the cohort by matching on constitutional determinants of CHD such as age and sex. Participants are identified by national identification number during the follow up. The level of serum key nutrients is compared in cases and controls. Univariate and multivariate association analyses will be performed to identify risk factors to CHD by using multivariate logistic regression model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37000
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• attend pre-pregnancy physical examination from 11 districts in Shanghai, OR pregnant women present at first antenatal care < 14 week of gestation
• plan to deliver in Shanghai

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• observation
This is an observational study

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

Ionescu-Ittu R, Marelli AJ, Mackie AS, Pilote L. Prevalence of severe congenital heart disease after folic acid fortification of grain products: time trend analysis in Quebec, Canada. BMJ. 2009 May 12;338:b1673. doi: 10.1136/bmj.b1673. — View Citation

Peyvandi S, Rychik J, Zhang X, Shea JA, Goldmuntz E. Preconceptual Folic Acid Use and Recurrence Risk Counseling for Congenital Heart Disease. Congenit Heart Dis. 2015 May-Jun;10(3):219-25. doi: 10.1111/chd.12206. Epub 2014 Jul 24. — View Citation

Reller MD, Strickland MJ, Riehle-Colarusso T, Mahle WT, Correa A. Prevalence of congenital heart defects in metropolitan Atlanta, 1998-2005. J Pediatr. 2008 Dec;153(6):807-13. doi: 10.1016/j.jpeds.2008.05.059. Epub 2008 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preconceptional maternal serum folate level	a serum sample collected at preconception and/or early conception will be used for examination	usually 6 months before pregnancy
Secondary	early conceptional maternal serum folate deficiency	a serum sample collected at early conception will be used for examination	first antenatal visit (usually 12th-16th gestational week)
Secondary	The status of serum Vitamin D level	a serum sample collected at preconception and/or first antenatal visit will be used for examination	periconception period ( defined as around 6 months before and the first 3 months of gestation
Secondary	Pre-conceptional maternal diet folic acid supplement intake	a questionnaire administered at preconception and early conception will be used for estimation based on the dose and frequency of supplements intake	preconception examination (usually 0-6 months before pregnancy)
Secondary	Peri-conceptional maternal plasma homocysteine level	a plasma sample collected at preconception and first antenatal visit will be used for examination	peri-conception examination ( defined as about 6 months before and 3 months after conception
Secondary	neonatal congenital heart disease(CHD) status	The newborn babies with heart murmurs(= 2 grade) and subnormal Pulse Oximetry reading positive will be considered positive-screened and echocardiography will performed.	Congenital heart disease screening during 6-72 hours after delivery
Secondary	Peri-conceptional paternal serum folate level	a serum sample collected at preconception and/or early conception will be used for examination	usually between 0-6 months before and 3 months after conception)