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Vitamin D and Preeclampsia (FEPED)

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ClinicalTrials.gov Identifier: NCT01648842
Recruitment Status : Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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

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.


Study Design

Study Type : Observational
Actual Enrollment : 3174 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vitamin D Status in Pregnant Women With Preeclampsia
Study Start Date : April 2012
Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Pregnant women


Outcome Measures

Primary Outcome Measures :
  1. Vitamin D (25OHD) status in the first trimester [ Time Frame: 11-14 (+6) weeks of amenorrhea ]
    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 :
  1. Vitamin D status in the third trimester [ Time Frame: 28-40 weeks of amenorrhea ]
    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

  2. Deficit un vitamin D [ Time Frame: 11-14 (+6) weeks of amenorrhea ]
    To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area

  3. Calcemia of the newborns [ Time Frame: 1 day (At the moment of the Guthrie test) ]
    To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648842


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648842     History of Changes
Other Study ID Numbers: AOM10113
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

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
Hypertension, Pregnancy-Induced
Pregnancy Complications
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents