Vitamin D and Preeclampsia

Pregnancy Clinical Trial

— FEPED  

Official title:

Vitamin D Status in Pregnant Women With Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648842
• Other study ID #: AOM10113
• Status: Completed
• Start date: April 17, 2012
• Est. completion date: March 16, 2015

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant women who will develop preeclampsia in the second or third trimester compare to a control group Primary purpose : To determine the vitamin D status in the first trimester in a large population of french pregnant women in order to evaluate the importance of the vitamin D deficiency in France and correlate this deficiency with preeclampsia

Description:

Primary purpose : To compare the vitamin D (25OHD) status, in the first trimester, in a group of patients with preeclampsia and a group of pregnant women without preeclampsia.

Secondary purpose : (i)To compare the vitamin D status in the third trimester in a group of patients with preeclampsia and a group of pregnant women without preeclampsia. (ii) To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area. (iii) To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D 100000U at 28 weeks Methodology : Multicenter (6 centers), Cohort, Nested case-control study Protocol : 4500 patients will be recruited. A blood sample will be performed : in the first trimester (11-14 weeks), in the third trimester (28-40 weeks), and cord blood. For each patient with preeclampsia, 4 controls will be taken from the cohort and matched by parity, race/ethnicity, maternal age, season, BMI. The serum concentration of 25OHD will be measured in all samples.A dosage of 25OHD will be performed in 1000 women from the initial cohort in order to calculate the prevalence of vitamin D deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3173
• Est. completion date: March 16, 2015
• Est. primary completion date: March 16, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant woman

• First trimester

• Singleton

• Affiliated to Social security policy

• Woman who gave informed consent

Exclusion Criteria:

• Hypercalcemia (>2.65 mmol/l) or any other phosphocalcic disease

• Hypertension (>140/90) from the first trimester

• Renal insufficiency (creatinine > 120µmol/l)

• Bone disease (osteogenesis imperfecta…)

• Lithium therapy

• Bowel malabsorption

• Kidney stones

Related Conditions & MeSH terms

• Hypercalcemia
• Neonatal Hypercalcemia
• Pre-Eclampsia
• Preeclampsia
• Pregnancy
• Vitamin D Deficiency
• Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml

Locations

Country	Name	City	State
France	Antoine Béclère Hospital	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D (25OHD) status in the first trimester	To compare the vitamin D (25OHD) status, in the first trimester, in a group of patients with preeclampsia and a group of pregnant women without preeclampsia	11-14 (+6) weeks of amenorrhea
Secondary	Vitamin D status in the third trimester	To compare the vitamin D status in the third trimester in a group of patients with preeclampsia and a group of pregnant women without preeclampsia	28-40 weeks of amenorrhea
Secondary	Deficit un vitamin D	To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area	11-14 (+6) weeks of amenorrhea
Secondary	Calcemia of the newborns	To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D	1 day (At the moment of the Guthrie test)