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Completed

NCT Number: NCT01648842

Vitamin D and 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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Vitamin D Status in Pregnant Women With Preeclampsia

Acronym: FEPED

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 24, 2012
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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