Overview

This trial is active, not recruiting.

Conditions vitamin d deficiency defined as serum 25ohd < 75 nmol/l or 30ng/ml, preeclampsia, neonatal hypercalcemia, pregnancy
Sponsor Assistance Publique - Hôpitaux de Paris
Start date April 2012
End date December 2015
Trial size 3174 participants
Trial identifier NCT01648842, AOM10113

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
Vitamin D (25OHD) status in the first trimester
time frame: 11-14 (+6) weeks of amenorrhea

Secondary Outcomes

Measure
Vitamin D status in the third trimester
time frame: 28-40 weeks of amenorrhea
Deficit un vitamin D
time frame: 11-14 (+6) weeks of amenorrhea
Calcemia of the newborns
time frame: 1 day (At the moment of the Guthrie test)

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Vitamin D Status in Pregnant Women With Preeclampsia
Principal investigator Alexandra BENACHI, MD/PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.