Clinical trial NCT01648842: Vitamin D and Preeclampsia
Official title: Vitamin D Status in Pregnant Women With Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml
Preeclampsia
Neonatal Hypercalcemia
Pregnancy
Keywords: Preeclampsia
Vitamin D deficiency
Pregnancy
First trimester
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 3173
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teh vitamin D status will be measured in a large population of french pregnant women (in the first trimester) in order to evaluate the importance of the vitamin D deficency in France and correlate this deficiency with preeclampsia

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D (25OHD) status in the first trimester
timeFrame: 11-14 (+6) weeks of amenorrhea
Secondary outcomes:
measure: Vitamin D status in the third trimester
timeFrame: 28-40 weeks of amenorrhea
measure: Deficit un vitamin D
timeFrame: 11-14 (+6) weeks of amenorrhea
measure: Calcemia of the newborns
timeFrame: 1 day (At the moment of the Guthrie test)
Other outcomes:
Locations:
city: Clamart
country: France
facility: Antoine Béclère Hospital
Study officials:
affiliation: Antoine Béclère Hospital
name: Alexandra BENACHI, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salakos E, Rabeony T, Courbebaisse M, Taieb J, Tsatsaris V, Guibourdenche J, Senat MV, Haidar H, Jani JC, Barglazan D, Maisonneuve E, Haguet MC, Winer N, Masson D, Elie C, Souberbielle JC, Benachi A. Relationship between vitamin D status in the first trimester of pregnancy and gestational diabetes mellitus - A nested case-control study. Clin Nutr. 2021 Jan;40(1):79-86. doi: 10.1016/j.clnu.2020.04.028. Epub 2020 Apr 25.