Vitamin D and Preeclampsia (FEPED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648842
First received: July 20, 2012
Last updated: June 25, 2014
Last verified: June 2014

July 20, 2012
June 25, 2014
April 2012
May 2015   (final data collection date for primary outcome measure)
Vitamin D (25OHD) status in the first trimester [ Time Frame: 11-14 (+6) weeks of amenorrhea ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01648842 on ClinicalTrials.gov Archive Site
  • Vitamin D status in the third trimester [ Time Frame: 28-40 weeks of amenorrhea ] [ Designated as safety issue: No ]
    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
  • Deficit un vitamin D [ Time Frame: 11-14 (+6) weeks of amenorrhea ] [ Designated as safety issue: No ]
    To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area
  • Calcemia of the newborns [ Time Frame: 1 day (At the moment of the Guthrie test) ] [ Designated as safety issue: No ]
    To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D
Same as current
Not Provided
Not Provided
 
Vitamin D and Preeclampsia
Vitamin D Status in Pregnant Women With Preeclampsia

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml
  • Preeclampsia
  • Neonatal Hypercalcemia
  • Pregnancy
Not Provided
Pregnant women
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4500
November 2015
May 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Alexandra BENACHI, MD, PhD +33145373376 alexandra.benachi@abc.aphp.fr
Contact: Laurence LECOMTE, PhD +33171196494 laurence.lecomte@nck.aphp.fr
France
 
NCT01648842
AOM10113
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Alexandra BENACHI, MD/PhD Antoine Béclère Hospital
Assistance Publique - Hôpitaux de Paris
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP