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NCT03882099 Clinical Trial

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

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Level in Patients With Pre-eclampsia, Eclampsia and Normal Full Term Pregnant

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03882099
Other study ID # 173019OBGYN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 17, 2019
Est. completion date October 2019

Study information
Verified date March 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date October 2019
Est. primary completion date September 17, 2019
Accepts healthy volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Determination of Vitamin D by ELISA
Blood samples

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare vitamin D levels in the three groups 6 months
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