Vitamin D and Preeclampsia (FEPED)

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

Study Overview

• Status: Completed
• Conditions: Pregnancy; Preeclampsia; Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml; Neonatal Hypercalcemia

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
• Enrollment (Actual): 3173

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Antoine Beclère Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D (25OHD) status in the first trimester	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	11-14 (+6) weeks of amenorrhea

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D status in the third trimester	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	28-40 weeks of amenorrhea
Deficit un vitamin D	To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area	11-14 (+6) weeks of amenorrhea
Calcemia of the newborns	To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D	1 day (At the moment of the Guthrie test)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Alexandra BENACHI, MD/PhD, Antoine Beclère Hospital

Publications and helpful links

General Publications

• Salakos E, Rabeony T, Courbebaisse M, Taieb J, Tsatsaris V, Guibourdenche J, Senat MV, Haidar H, Jani JC, Barglazan D, Maisonneuve E, Haguet MC, Winer N, Masson D, Elie C, Souberbielle JC, Benachi A. Relationship between vitamin D status in the first trimester of pregnancy and gestational diabetes mellitus - A nested case-control study. Clin Nutr. 2021 Jan;40(1):79-86. doi: 10.1016/j.clnu.2020.04.028. Epub 2020 Apr 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2012
• Primary Completion (ACTUAL): March 16, 2015
• Study Completion (ACTUAL): March 16, 2015

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (ESTIMATE): July 24, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Vitamin D deficiency; Preeclampsia; First trimester
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Pregnancy Complications; Calcium Metabolism Disorders; Hypertension, Pregnancy-Induced; Water-Electrolyte Imbalance; Vitamin D Deficiency; Pre-Eclampsia; Hypercalcemia
• Other Study ID Numbers: AOM10113