Vitamin D and Preeclampsia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Vitamin D Status in Pregnant Women With Preeclampsia

Conditions
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Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml, Preeclampsia, Neonatal Hypercalcemia, Pregnancy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, Vitamin D deficiency, Pregnancy, First trimester