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
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vitamin D Status in Pregnant Women With Preeclampsia

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 4500
Study Start Date: April 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant women

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648842

Contacts
Contact: Alexandra BENACHI, MD, PhD +33145373376 alexandra.benachi@abc.aphp.fr
Contact: Laurence LECOMTE, PhD +33171196494 laurence.lecomte@nck.aphp.fr

Locations
France
Antoine Béclère Hospital Recruiting
Clamart, France, 92141
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alexandra BENACHI, MD/PhD Antoine Béclère Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648842     History of Changes
Other Study ID Numbers: AOM10113
Study First Received: July 20, 2012
Last Updated: June 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preeclampsia
Vitamin D deficiency
Pregnancy
First trimester

Additional relevant MeSH terms:
Pre-Eclampsia
Vitamin D Deficiency
Hypercalcemia
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypertension, Pregnancy-Induced
Pregnancy Complications
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014