Vitamin D Level and Its Relation to Pre-eclampsia and Eclampsia

March 17, 2019 updated by: Yahia El-Faissal, Cairo University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12573
        • Recruiting
        • Cairo University
        • Contact:
        • Principal Investigator:
          • Omneya M Osman, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • Age 20-35 years
  • Gestational age 30-40 weeks

Exclusion Criteria:

  • Twin pregnancy
  • Other medical conditions during pregnancy
  • Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women with pre-eclampsia
Diagnostic test: Determination of Vitamin D by ELISA
Blood samples
Pregnant women with eclampsia
Diagnostic test: Determination of Vitamin D by ELISA
Blood samples
Normotensive pregnant women
Diagnostic test: Determination of Vitamin D by ELISA
Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare vitamin D levels in the three groups
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2019

Primary Completion (Anticipated)

September 17, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 17, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173019OBGYN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Publication in journals and presentation in conferences

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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