PreeclampsiaNCT01806454
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China
A study testing calcium in people with Preeclampsia, run by West China Second University Hospital at 1 site in China.
Trial summary
the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Nov 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia
Who cannot join
- first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )
Trial locations and contacts
1 site in 1 country.
peng chen contact
About this study
Official title: Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial
the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable
- Conditions
- Preeclampsia
- Being tested
- calcium
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calciumDrug
| Study group | Role | What they receive |
|---|---|---|
| calcium A | Active comparator | tablets, 600mg per day,till birth Receives: Drug: calcium |
| calcium B | Active comparator | tablets,1200mg per day,till birth Receives: Drug: calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pre-eclampsia
Measured: postpartum forty-two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Academy of Medical Sciences, Guang'an people's hospital of Sichuan province, pengzhou shi fuyou baojianyuan, The First People's Hospital of Neijiang, Suining Central Hospital, Sichuan Provincial Maternal and Child Health Care Hospital, Chengdu Women's and Children's Central Hospital
- Responsible party
- Principal investigator, Xinghui Liu, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806454
- Sponsor's protocol ID
- hx2ck1
- Status last verified
- Apr 2014
- First submitted
- 1 Mar 2013
- Last updated
- 25 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial
- ClinicalTrials.gov ID
- NCT01806454
- Acronym / sponsor ID
- hx2ck1
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Collaborators
- Sichuan Academy of Medical Sciences, Guang'an people's hospital of Sichuan province, pengzhou shi fuyou baojianyuan, The First People's Hospital of Neijiang, Suining Central Hospital, Sichuan Provincial Maternal and Child Health Care Hospital, Chengdu Women's and Children's Central Hospital
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (estimated)
- First posted
- 7 Mar 2013 (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 calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium A | Active comparator | Drug: calciumtablets, 600mg per day,till birth |
| calcium B | Active comparator | Drug: calciumtablets,1200mg per day,till birth |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia
Key exclusion criteria (1 listed)
- first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )
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 |
|---|---|---|
| calcium | Drug | calcium A, calcium B |
Primary outcome
incidence of pre-eclampsia
Time frame: postpartum forty-two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
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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.
peng chen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium in people with Preeclampsia, run by West China Second University Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 25 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact peng chen (cpyxwd007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of pre-eclampsia (time frame: postpartum forty-two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2015.