Congenital Heart DiseaseNCT02537392
Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease
A study testing Vitamin B Complex and Folic Acid, Iron and Folic Acid and Folic Acid in people with Congenital Heart Disease, run by Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this study is to determine whether daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid given to women during peri-conception can reduce the risk of congenital heart disease when compared with folic acid alone. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Vitamin B Complex and Folic Acid, Iron and Folic Acid and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,315 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 2019
- Phase
- Interventional
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women of reproductive age (15-49 years) who reside in the study areas;
- Women who are prepared for pregnancy in 1-3 months or have already been pregnant for less than 20 months;
- Women who have provided written informed consent.
Who cannot join
- Women who have already taken supplements containing vitamin B complex, iron, or folic acid for more than two weeks at enrollment;
- Women who have given birth to children with congenital heart disease or other birth defects before;
- Women with diabetes;
- women with severe heart, liver or kidney disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Xi'an Jiaotong University College of Medicine
Xi'an, Shaanxi, 710061
About this study
Official title: Primary Prevention of Multi-micronutrient Supplementation During Peri-conception Against Congenital Heart Disease: A Community-based Randomised Controlled Trial in China
The purpose of this study is to determine whether daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid given to women during peri-conception can reduce the risk of congenital heart disease when compared with folic acid alone.
Read the detailed description
Congenital heart disease (CHD) is among the most prevalent congenital abnormalities with an incidence of about 8-12/1,000 live births, and is also the leading cause of infant morbidity and death from birth defects. A series of studies pointed out that the poor nutritional status of the mother during peri-conception might be the important cause of CHD. In maternal folic acid/ vitamin B deficiency homocysteine accumulates in the serum, and elevated circulating homocysteine concentrations have been associated with the risk of CHD. However, it is still questionable whether multiple vitamin B supplements during peri-conception can reduce CHD risk more effectively compared with the supplement of folic acid alone. Moreover, one randomized controlled trial performed in Shaanxi China confirmed that the supplement of iron and folic acid during pregnancy can significantly reduce early neonatal deaths. It is noteworthy that one-fourth of newborn deaths are attributable to birth defects. Thus, it is worthwhile to investigate whether iron supplement can reduce the risk of CHD.
This community-based randomized controlled trial will assess and compare the impact of daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid vs. folic acid alone given to women during peri-conception on CHD. It will also assess the effects of the three different supplementations on other pregnancy outcomes and maternal health. The study will be conducted in three rural poor counties including Xunyi, Changwu, and Bin, which are located in Shaanxi Province of Northwest China. All participants will sign informed consent before the study. The investigators hypothesize that the newborn infants of women receiving supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid will experience a reduction in the prevalence of infants with the pulse oxygen saturation less than 95% and other adverse pregnancy outcomes compared with those receiving folic acid alone. The results of this trial will provide evidence needed to formulate policy on maternal micronutrient supplementation during peri-conception and the rationale for the necessary investment of public funds to implement appropriate programs against birth defects.
- Conditions
- Congenital Heart Disease
- Being tested
- Vitamin B Complex and Folic Acid, Iron and Folic Acid, Folic Acid
- 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.
Vitamin B Complex and Folic AcidDietary supplement
Daily oral dose containing 2 mg vitamin B1, 2 mg vitamin B2, 2 mg vitamin B6, 2 μg vitamin B12, 2 mg calcium pantothenate, 15 mg nicotinamide and 0.4 mg folic acid.
Iron and Folic AcidDietary supplement
Daily oral dose of 60 mg iron and 0.4 mg folic acid.
Folic AcidDietary supplement
Daily oral dose of 0.4 mg folic acid.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B Complex and Folic Acid | Experimental | Daily supplements containing vitamin B1 (2 mg), vitamin B2 (2 mg), vitamin B6 (2 mg), vitamin B12 (2 μg), calcium pantothenate (2 mg), nicotinamide (15 mg) and folic acid (0.4 mg). Receives: Dietary Supplement: Vitamin B Complex and Folic Acid |
| Iron and Folic Acid | Experimental | Daily supplements of iron (60 mg) and folic acid (0.4 mg). Receives: Dietary Supplement: Iron and Folic Acid |
| Folic Acid | Active comparator | Daily supplement of 0.4 mg folic acid. Receives: Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal pulse oximetry oxygen saturation measured by pulse oximetry
Neonatal pulse oximetry oxygen saturation (SpO2) is tested by pulse oximetry in babies aged between 6 h and 72 h after birth. Pulse oximetry testing is repeated 4 h later if the first measurement is between 90% and 95%. The result of SpO2 will be reported as a dichotomous variable, in which the result is deemed positive if an SpO2 less than 95% is obtained both on the right hand and on either foot on two measures, separated by 4 h; a difference between the two extremities was more than 3% on two measures, separated by 4 h; or any measure is less than 90%. The result of SpO2 will also be reported as a continuous variable.
Measured: 6-72 hours after delivery
Secondary outcomes (11)
Incidence of congenital heart disease and the subtypes
Congenital heart disease will be diagnosed by trained clinicians with the help of echocardiography, pulse oximetry, clinical examination, cardiac surgery, or autopsy. The incidence of congenital heart disease and the subtypes will be reported in each group.
Measured: Half a year after delivery
Incidence of birth defects and the subtypes
Birth defects will be diagnosed by trained clinicians. The incidence of birth defects and the subtypes will be reported in each group.
Measured: Half a year after delivery
Birth weight measured by baby scale
Birth weight will be measured within 1 hour of delivery using a baby scale with the precision to the nearest 50 gram.
Measured: Within 1 hours of delivery
Incidence of low birth weight
Birth weight will be measured within 1 hour of delivery using a baby scale. The incidence of low birth weight will be reported in each group based on the criteria of birth weight less than 2500 gram.
Measured: Within 1 hour of delivery
Gestational age at birth
Gestational age at birth will be measured as completed days based on the last menstrual period.
Measured: At delivery
Incidence of preterm birth
Gestational age at birth will be measured as completed days based on the last menstrual period. The incidence of preterm birth (infant born less than 37 weeks gestational age) will be reported in each group.
Measured: At delivery
Incidence of perinatal mortality
The incidence of perinatal mortality (Infants death between 28 weeks of gestational duration and 7 days after delivery) will be reported in each group.
Measured: Between 28 weeks of gestational duration and 7 days after delivery
Incidence of stillbirth
The incidence of stillbirth (infants death at delivery) will be reported in each group.
Measured: At delivery
Incidence of neonatal mortality
The incidence of neonatal mortality (infants death during the first 28 days after birth) will be reported in each group.
Measured: First 28 days after birth
Incidence of early neonatal mortality
The incidence of early neonatal mortality (infants death during the first 7 days after birth) will be reported in each group.
Measured: First 7 days after birth
Incidence of pregnancy complications: hypertension, preeclampsia, antepartum haemorrhage, and infections
Pregnancy complications (hypertension, preeclampsia, antepartum haemorrhage, and infections) will be diagnosed by trained clinicians during antenatal care checks. All information will be recorded in the pregnant women's medical records of antenatal care checks and delivery. The incidence of hypertension, preeclampsia, antepartum haemorrhage, and infections among participants will be reported in each group.
Measured: After enrollment until at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaomei Yang, Xi'an Jiaotong University
- Investigators
- Hong Yan, Professor, Principal investigator, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537392
- Sponsor's protocol ID
- NSFC81230016
- Status last verified
- Jul 2020
- First submitted
- 27 Aug 2015
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mi B, Wen X, Li S, Liu D, Lei F, Liu R, Shen Y, Chen Y, Zeng L, Liu X, Dang S, Yan H. Vegetable dietary pattern associated with low risk of preeclampsia possibly through reducing proteinuria. Pregnancy Hypertens. 2019 Apr;16:131-138. doi: 10.1016/j.preghy.2019.04.001. Epub 2019 Apr 8.
PubMed 31056148
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Multi-micronutrient Supplementation During Peri-conception Against Congenital Heart Disease: A Community-based Randomised Controlled Trial in China
- ClinicalTrials.gov ID
- NCT02537392
- Acronym / sponsor ID
- NSFC81230016
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,315 participants (actual)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Sep 2015 (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 purpose of this study is to determine whether daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid given to women during peri-conception can reduce the risk of congenital heart disease when compared with folic acid alone.
Detailed description
Congenital heart disease (CHD) is among the most prevalent congenital abnormalities with an incidence of about 8-12/1,000 live births, and is also the leading cause of infant morbidity and death from birth defects. A series of studies pointed out that the poor nutritional status of the mother during peri-conception might be the important cause of CHD. In maternal folic acid/ vitamin B deficiency homocysteine accumulates in the serum, and elevated circulating homocysteine concentrations have been associated with the risk of CHD. However, it is still questionable whether multiple vitamin B supplements during peri-conception can reduce CHD risk more effectively compared with the supplement of folic acid alone. Moreover, one randomized controlled trial performed in Shaanxi China confirmed that the supplement of iron and folic acid during pregnancy can significantly reduce early neonatal deaths. It is noteworthy that one-fourth of newborn deaths are attributable to birth defects. Thus, it is worthwhile to investigate whether iron supplement can reduce the risk of CHD.
This community-based randomized controlled trial will assess and compare the impact of daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid vs. folic acid alone given to women during peri-conception on CHD. It will also assess the effects of the three different supplementations on other pregnancy outcomes and maternal health. The study will be conducted in three rural poor counties including Xunyi, Changwu, and Bin, which are located in Shaanxi Province of Northwest China. All participants will sign informed consent before the study. The investigators hypothesize that the newborn infants of women receiving supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid will experience a reduction in the prevalence of infants with the pulse oxygen saturation less than 95% and other adverse pregnancy outcomes compared with those receiving folic acid alone. The results of this trial will provide evidence needed to formulate policy on maternal micronutrient supplementation during peri-conception and the rationale for the necessary investment of public funds to implement appropriate programs against birth defects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin B Complex and Folic Acid | Experimental | Dietary Supplement: Vitamin B Complex and Folic AcidDaily supplements containing vitamin B1 (2 mg), vitamin B2 (2 mg), vitamin B6 (2 mg), vitamin B12 (2 μg), calcium pantothenate (2 mg), nicotinamide (15 mg) and folic acid (0.4 mg). |
| Iron and Folic Acid | Experimental | Dietary Supplement: Iron and Folic AcidDaily supplements of iron (60 mg) and folic acid (0.4 mg). |
| Folic Acid | Active comparator | Dietary Supplement: Folic AcidDaily supplement of 0.4 mg folic acid. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women of reproductive age (15-49 years) who reside in the study areas;
- Women who are prepared for pregnancy in 1-3 months or have already been pregnant for less than 20 months;
- Women who have provided written informed consent.
Key exclusion criteria (4 listed)
- Women who have already taken supplements containing vitamin B complex, iron, or folic acid for more than two weeks at enrollment;
- Women who have given birth to children with congenital heart disease or other birth defects before;
- Women with diabetes;
- women with severe heart, liver or kidney disease.
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 |
|---|---|---|
| Vitamin B Complex and Folic AcidDaily oral dose containing 2 mg vitamin B1, 2 mg vitamin B2, 2 mg vitamin B6, 2 μg vitamin B12, 2 mg calcium pantothenate, 15 mg nicotinamide and 0.4 mg folic acid. | Dietary supplement | Vitamin B Complex and Folic Acid |
| Iron and Folic AcidDaily oral dose of 60 mg iron and 0.4 mg folic acid. | Dietary supplement | Iron and Folic Acid |
| Folic AcidDaily oral dose of 0.4 mg folic acid. | Dietary supplement | Folic Acid |
Primary outcome
Neonatal pulse oximetry oxygen saturation measured by pulse oximetry
Time frame: 6-72 hours after delivery
Neonatal pulse oximetry oxygen saturation (SpO2) is tested by pulse oximetry in babies aged between 6 h and 72 h after birth. Pulse oximetry testing is repeated 4 h later if the first measurement is between 90% and 95%. The result of SpO2 will be reported as a dichotomous variable, in which the result is deemed positive if an SpO2 less than 95% is obtained both on the right hand and on either foot on two measures, separated by 4 h; a difference between the two extremities was more than 3% on two measures, separated by 4 h; or any measure is less than 90%. The result of SpO2 will also be reported as a continuous variable.
11 secondary outcomes
Incidence of congenital heart disease and the subtypes
Time frame: Half a year after delivery
Incidence of birth defects and the subtypes
Time frame: Half a year after delivery
Birth weight measured by baby scale
Time frame: Within 1 hours of delivery
Incidence of low birth weight
Time frame: Within 1 hour of delivery
Gestational age at birth
Time frame: At delivery
Incidence of preterm birth
Time frame: At delivery
Incidence of perinatal mortality
Time frame: Between 28 weeks of gestational duration and 7 days after delivery
Incidence of stillbirth
Time frame: At delivery
Incidence of neonatal mortality
Time frame: First 28 days after birth
Incidence of early neonatal mortality
Time frame: First 7 days after birth
Incidence of pregnancy complications: hypertension, preeclampsia, antepartum haemorrhage, and infections
Time frame: After enrollment until at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 31056148Mi B, Wen X, Li S, Liu D, Lei F, Liu R, Shen Y, Chen Y, Zeng L, Liu X, Dang S, Yan H. Vegetable dietary pattern associated with low risk of preeclampsia possibly through reducing proteinuria. Pregnancy Hypertens. 2019 Apr;16:131-138. doi: 10.1016/j.preghy.2019.04.001. Epub 2019 Apr 8.
- Individual participant dataSharing planned: No
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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.
Hong Yan, Professor principal investigator
Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B Complex and Folic Acid, Iron and Folic Acid and Folic Acid in people with Congenital Heart Disease, run by Xi'an Jiaotong 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 3 inclusion and 4 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 8 Jul 2020. 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?
Neonatal pulse oximetry oxygen saturation measured by pulse oximetry (time frame: 6-72 hours after delivery). 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 NCT02537392, which also lists 1 linked publication.
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 8 Jul 2020.