Vitamin D DeficiencyNCT03882099
Vitamin D Level and Its Relation to Pre-eclampsia and Eclampsia
An observational study of Vitamin D Deficiency and Pre-Eclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
To compare 25(OH)D level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of Vitamin D deficiency among the 3 groups. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Vitamin D Deficiency, Pre-Eclampsia, Eclampsia, Antepartum
- What is being tested?
- Determination of Vitamin D by ELISA
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Mar 2019to Oct 2019
- 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 20 to 35 years
- Women only
- Adult
Study population: 200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study
Who may be able to join
- Age 20-35 years
- Gestational age 30-40 weeks
Who cannot join
- Twin pregnancy
- Other medical conditions during pregnancy
- Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12573
Yahia El-Faissal, M.D., +201001844020, yahiaelfaissal@gmail.com
Omneya M Osman, M.D.
About this study
Official title: Vitamin D Level in Patients With Pre-eclampsia, Eclampsia and Normal Full Term Pregnant
To compare 25(OH)D level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of Vitamin D deficiency among the 3 groups.
Read the detailed description
200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study (from March 2019 till September 2019). 25(OH) D level will be measured for the three groups.
- Preeclampsia is defined as systolic BP >140 and/or diastolic BP>90 on two occasions, 4 hours apart in pregnant females>20 weeks, plus proteinuria >/= 1+ urine dipstick protein.
- Eclampsia defined as tonic-clonic seizures in women with pre-eclampsia.
- Controls are normotensive pregnant females with no proteinuria and no other medical disorders.
- The determination of 25(OH) D is based on a competitive enzyme-linked immunosorbant assay (ELISA) using the 25(OH)D3/D2 ELISA system (ORGENTIC DIAGNOSTIKA GmbH, Germany)
Inclusion criteria:
Age 20-35 years Gestational age 30-40 weeks
Exclsion criteria:
Twin pregnancy Other medical conditions during prrgnancy Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment.
- Conditions
- Vitamin D Deficiency, Pre-Eclampsia, Eclampsia, Antepartum
- Being tested
- Determination of Vitamin D by ELISA
- Medical subject headings
- Vitamin D Deficiency, Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of Vitamin D by ELISADiagnostic test
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with pre-eclampsia | Not described Receives: Diagnostic Test: Determination of Vitamin D by ELISA | |
| Pregnant women with eclampsia | Not described Receives: Diagnostic Test: Determination of Vitamin D by ELISA | |
| Normotensive pregnant women | Not described Receives: Diagnostic Test: Determination of Vitamin D by ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare vitamin D levels in the three groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start17 Mar 2019
- Primary completion17 Sep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahia El-Faissal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882099
- Sponsor's protocol ID
- 173019OBGYN
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication in journals and presentation in conferences
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Level in Patients With Pre-eclampsia, Eclampsia and Normal Full Term Pregnant
- ClinicalTrials.gov ID
- NCT03882099
- Acronym / sponsor ID
- 173019OBGYN
- Conditions
- Vitamin D Deficiency, Pre-Eclampsia, Eclampsia, Antepartum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Mar 2019 (actual)
- Primary completion
- 17 Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 20 Mar 2019 (actual)
- 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.
To compare 25(OH)D level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of Vitamin D deficiency among the 3 groups.
Detailed description
200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study (from March 2019 till September 2019). 25(OH) D level will be measured for the three groups.
- Preeclampsia is defined as systolic BP >140 and/or diastolic BP>90 on two occasions, 4 hours apart in pregnant females>20 weeks, plus proteinuria >/= 1+ urine dipstick protein.
- Eclampsia defined as tonic-clonic seizures in women with pre-eclampsia.
- Controls are normotensive pregnant females with no proteinuria and no other medical disorders.
- The determination of 25(OH) D is based on a competitive enzyme-linked immunosorbant assay (ELISA) using the 25(OH)D3/D2 ELISA system (ORGENTIC DIAGNOSTIKA GmbH, Germany)
Inclusion criteria:
Age 20-35 years Gestational age 30-40 weeks
Exclsion criteria:
Twin pregnancy Other medical conditions during prrgnancy Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with pre-eclampsia | – | Diagnostic Test: Determination of Vitamin D by ELISA |
| Pregnant women with eclampsia | – | Diagnostic Test: Determination of Vitamin D by ELISA |
| Normotensive pregnant women | – | Diagnostic Test: Determination of Vitamin D by ELISA |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study
Key inclusion criteria (2 listed)
- Age 20-35 years
- Gestational age 30-40 weeks
Key exclusion criteria (3 listed)
- Twin pregnancy
- Other medical conditions during pregnancy
- Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment
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 |
|---|---|---|
| Determination of Vitamin D by ELISABlood samples | Diagnostic test | Normotensive pregnant women, Pregnant women with eclampsia, Pregnant women with pre-eclampsia |
Primary outcome
To compare vitamin D levels in the three groups
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: Undecided. Publication in journals and presentation in conferences
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Pre-Eclampsia, run by Cairo University at 1 site in Egypt.
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 3 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 20 Mar 2019. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare vitamin D levels in the three groups (time frame: 6 months). 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 20 Mar 2019.