Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/mlFEPEDNCT01648842
Vitamin D and Preeclampsia
An observational study of Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml and Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml, Preeclampsia, Neonatal Hypercalcemia
- How many people
- 3,173 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2012to 16 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Pregnant woman
- First trimester
- Singleton
- Affiliated to Social security policy
- Woman who gave informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml, Preeclampsia, Neonatal Hypercalcemia, Pregnancy
- Keywords
- Preeclampsia, Vitamin D deficiency, Pregnancy, First trimester
- Medical subject headings
- Pre-Eclampsia, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 11-14 (+6) weeks of amenorrhea
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 1 day (At the moment of the Guthrie test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start17 Apr 2012
- Primary completion16 Mar 2015
- Study completion16 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/mlStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alexandra BENACHI, MD/PhD, Principal investigator, Antoine Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648842
- Sponsor's protocol ID
- AOM10113
- Acronym
- FEPED
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2012
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32448701
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status in Pregnant Women With Preeclampsia
- ClinicalTrials.gov ID
- NCT01648842
- Acronym / sponsor ID
- FEPED / AOM10113
- Conditions
- Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml, Preeclampsia, Neonatal Hypercalcemia, Pregnancy
- Keywords
- Preeclampsia, Vitamin D deficiency, Pregnancy, First trimester
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,173 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 17 Apr 2012 (actual)
- Primary completion
- 16 Mar 2015 (actual)
- Study completion
- 16 Mar 2015 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Pregnant woman
- First trimester
- Singleton
- Affiliated to Social security policy
- Woman who gave informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Vitamin D status in the third trimester
Time frame: 28-40 weeks of amenorrhea
Deficit un vitamin D
Time frame: 11-14 (+6) weeks of amenorrhea
Calcemia of the newborns
Time frame: 1 day (At the moment of the Guthrie test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 32448701Salakos 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra BENACHI, MD/PhD principal investigator
Antoine Béclère Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml and Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D (25OHD) status in the first trimester (time frame: 11-14 (+6) weeks of amenorrhea). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01648842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.