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

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ClinicalTrials.gov Identifier: NCT03882099
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yahia El-Faissal, Cairo University

Brief 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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Pre-Eclampsia Eclampsia, Antepartum Diagnostic Test: Determination of Vitamin D by ELISA

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vitamin D Level in Patients With Pre-eclampsia, Eclampsia and Normal Full Term Pregnant
Actual Study Start Date : March 17, 2019
Estimated Primary Completion Date : September 17, 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. To compare vitamin D levels in the three groups [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882099


Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 12573
Contact: Yahia El-Faissal, M.D.    +201001844020    yahiaelfaissal@gmail.com   
Principal Investigator: Omneya M Osman, M.D.         
Sponsors and Collaborators
Cairo University

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Responsible Party: Yahia El-Faissal, Dr, Cairo University
ClinicalTrials.gov Identifier: NCT03882099     History of Changes
Other Study ID Numbers: 173019OBGYN
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Publication in journals and presentation in conferences

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamin D Deficiency
Hypertension, Pregnancy-Induced
Vitamin D
Eclampsia
Pre-Eclampsia
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Pregnancy Complications
Vitamins
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents