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Vitamin D and Preeclampsia (FEPED)

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ClinicalTrials.gov Identifier: NCT01648842
Recruitment Status : Unknown
Verified June 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date July 20, 2012
First Posted Date July 24, 2012
Last Update Posted Date June 24, 2016
Study Start Date April 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2012)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01648842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 23, 2012)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin D and Preeclampsia
Official Title Vitamin D Status in Pregnant Women 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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml
  • Preeclampsia
  • Neonatal Hypercalcemia
  • Pregnancy
Intervention Not Provided
Study Groups/Cohorts Pregnant women
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: April 20, 2015)
3174
Original Estimated Enrollment
 (submitted: July 23, 2012)
4500
Estimated Study Completion Date July 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01648842
Other Study ID Numbers AOM10113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Alexandra BENACHI, MD/PhD Antoine Béclère Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2016