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Congenital Heart DiseasePKNFCHDNCT02737644

Peri-conception Key Nutritional Factors and Congenital Heart Disease

An observational study of Congenital Heart Disease, run by Children's Hospital of Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Congenital Heart Disease
What is being tested?
observation
How many people
37,000 participants
Where
1 siteChina
Study dates
Mar 2016to 30 Dec 2020
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
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All couples attending pre-pregnancy physical examination from 11 districts in Shanghai from March 2016, or pregnant women present at first antenatal care < 14 week of gestation

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

China1 site

  • Children Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
observation
Keywords
Congenital Heart Disease, Key Nutritional Factors, conception, pregnant
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observationOther

    Also called This is an observational study

    This is an observational study

Study groups in NCT02737644
Study groupRoleWhat they receive
CHD birth cohortCases are identified as those whose newborns screened and confirmed with CHD during the follow-up and four age- and delivery-hospital matched controls are selected for each case from the rest of the cohort.
Receives: Other: observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. preconceptional maternal serum folate level

    a serum sample collected at preconception and/or early conception will be used for examination

    Measured: usually 6 months before pregnancy

Secondary outcomes (6)

  1. early conceptional maternal serum folate deficiency

    a serum sample collected at early conception will be used for examination

    Measured: first antenatal visit (usually 12th-16th gestational week)

  2. The status of serum Vitamin D level

    a serum sample collected at preconception and/or first antenatal visit will be used for examination

    Measured: periconception period ( defined as around 6 months before and the first 3 months of gestation

  3. 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

    Measured: preconception examination (usually 0-6 months before pregnancy)

  4. Peri-conceptional maternal plasma homocysteine level

    a plasma sample collected at preconception and first antenatal visit will be used for examination

    Measured: peri-conception examination ( defined as about 6 months before and 3 months after conception

  5. 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.

    Measured: Congenital heart disease screening during 6-72 hours after delivery

  6. Peri-conceptional paternal serum folate level

    a serum sample collected at preconception and/or early conception will be used for examination

    Measured: usually between 0-6 months before and 3 months after conception)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

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
Prospective
Enrolment
37,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02737644
Sponsor's protocol ID
GWIV24_v1
Acronym
PKNFCHD
Status last verified
Mar 2021
First submitted
3 Apr 2016
Last updated
11 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18657826

  • 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.

    PubMed 19436079

  • 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.

    PubMed 25059817

  • Chen X, Zhang Y, Chen H, Dou Y, Wang Y, He W, Ma X, Sheng W, Yan W, Huang G. Association Between Serum Glycated Hemoglobin Levels at Early Gestation and the Risk of Subsequent Pregnancy Loss in Pregnant Women Without Diabetes Mellitus: Prospective Cohort Study. JMIR Public Health Surveill. 2023 Dec 12;9:e46986. doi: 10.2196/46986.

    PubMed 38085559

  • Chen H, Zhang Y, Wang D, Chen X, Li M, Huang X, Jiang Y, Dou Y, Wang Y, Ma X, Sheng W, Jia B, Yan W, Huang G; SPCC (Shanghai Preconception Cohort) Group. Periconception Red Blood Cell Folate and Offspring Congenital Heart Disease : Nested Case-Control and Mendelian Randomization Studies. Ann Intern Med. 2022 Sep;175(9):1212-1220. doi: 10.7326/M22-0741. Epub 2022 Aug 23.

    PubMed 35994746

  • Wang D, Zhang Y, Jiang Y, Ye Y, Ji M, Dou Y, Chen X, Li M, Ma X, Sheng W, Huang G, Yan W; SPCC group. Shanghai Preconception Cohort (SPCC) for the association of periconceptional parental key nutritional factors with health outcomes of children with congenital heart disease: a cohort profile. BMJ Open. 2019 Nov 24;9(11):e031076. doi: 10.1136/bmjopen-2019-031076.

    PubMed 31767586

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Heart Disease, run by Children's Hospital of Fudan University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 11 Mar 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

preconceptional maternal serum folate level (time frame: usually 6 months before pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02737644, which also lists 6 linked publications.

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 11 Mar 2021.

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