Vitamin D DeficiencyPCVDDPWSNCT02904720
Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland
An observational study of Vitamin D Deficiency, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at the investigators' clinic. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 1,199 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Feb 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the pregnant women attending prenatal care and giving birth at birth at our clinic
Who may be able to join
- Pregnant women attending prenatal care at our clinic who had a vitamin D blood-testing at admission
Who cannot join
- Pregnant women lost to follow-up, Birth outside our clinic
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at the investigators' clinic. The further purposes are to identify the population at risk for vitamin D deficiency and to analyse whether vitamin D deficiency is associated with pregnancy complications.
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D; Pregnancy
- Medical subject headings
- Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vitamin D deficiency
Number of patients with vitamin D deficiency after testing of vitamin D blood level at admission for prenatal care in our clinic
Measured: Between the 1th and the 36th week of pregnancy
Secondary outcomes (7)
BMI as a risk factor for vitamin D deficiency
Presence of an association between the patient's BMI and their vitamin D blood level?
Measured: Between the 1th and the 36th week of pregnancy
Ethnicity as a risk factor for vitamin D deficiency
Presence of an association between the patient's ethnicity and their vitamin D blood level?
Measured: Between the 1th and the 36th week of pregnancy
Age as risk factor for vitamin D deficiency
Presence of an association between the patient's age and their vitamin D blood level ?
Measured: Between the 1th and the 36th week of pregnancy
Period of the year as risk factor for vitamin D deficiency
Presence of an association between the period of the year at the time of the blood testing and the vitamin D blood level?
Measured: Between the 1th and the 36th week of pregnancy
Smoking Status as risk factor for vitamin D deficiency
Presence of an association between the patient's smoking status and the vitamin D blood level ?
Measured: Between the 1th and the 36th week of pregnancy
Association between vitamin D blood level and gestational diabetes mellitus
Presence of an association between the vitamin D blood level and the occurrence of gestational diabetes mellitus?
Measured: Between the 1th and the 36th week of pregnancy
Association between vitamin D blood level and gestational hypertension and preeclampsia
Presence of an association between the vitamin D blood level and the occurrence of gestational hypertension and preeclampsia ?
Measured: Between the 1th and the 36th week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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 DeficiencyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Significantis GmbH
- Responsible party
- Sponsor
- Investigators
- Daniel Surbek, Professor, Study director, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904720
- Sponsor's protocol ID
- 2015-00063
- Other IDs
- 2015
- Acronym
- PCVDDPWS
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Christoph P, Challande P, Raio L, Surbek D. High prevalence of severe vitamin D deficiency during the first trimester in pregnant women in Switzerland and its potential contributions to adverse outcomes in the pregnancy. Swiss Med Wkly. 2020 May 28;150:w20238. doi: 10.4414/smw.2020.20238. eCollection 2020 May 18.
PubMed 32502277
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland
- ClinicalTrials.gov ID
- NCT02904720
- Acronym / sponsor ID
- PCVDDPWS / 2015-00063
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D; Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Significantis GmbH
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Sep 2016 (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.
The purpose of this study is to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at the investigators' clinic. The further purposes are to identify the population at risk for vitamin D deficiency and to analyse whether vitamin D deficiency is associated with pregnancy complications.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the pregnant women attending prenatal care and giving birth at birth at our clinic
Key inclusion criteria (1 listed)
- Pregnant women attending prenatal care at our clinic who had a vitamin D blood-testing at admission
Key exclusion criteria (1 listed)
- Pregnant women lost to follow-up, Birth outside our clinic
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
Prevalence of vitamin D deficiency
Time frame: Between the 1th and the 36th week of pregnancy
Number of patients with vitamin D deficiency after testing of vitamin D blood level at admission for prenatal care in our clinic
7 secondary outcomes
BMI as a risk factor for vitamin D deficiency
Time frame: Between the 1th and the 36th week of pregnancy
Ethnicity as a risk factor for vitamin D deficiency
Time frame: Between the 1th and the 36th week of pregnancy
Age as risk factor for vitamin D deficiency
Time frame: Between the 1th and the 36th week of pregnancy
Period of the year as risk factor for vitamin D deficiency
Time frame: Between the 1th and the 36th week of pregnancy
Smoking Status as risk factor for vitamin D deficiency
Time frame: Between the 1th and the 36th week of pregnancy
Association between vitamin D blood level and gestational diabetes mellitus
Time frame: Between the 1th and the 36th week of pregnancy
Association between vitamin D blood level and gestational hypertension and preeclampsia
Time frame: Between the 1th and the 36th week of pregnancy
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 19 Sep 2016.
- Derived from this study: PubMed 32502277Christoph P, Challande P, Raio L, Surbek D. High prevalence of severe vitamin D deficiency during the first trimester in pregnant women in Switzerland and its potential contributions to adverse outcomes in the pregnancy. Swiss Med Wkly. 2020 May 28;150:w20238. doi: 10.4414/smw.2020.20238. eCollection 2020 May 18.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Daniel Surbek, Professor study director
Insel Gruppe AG, University Hospital Bern
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, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 1 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 19 Sep 2016. 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 Switzerland. 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?
Prevalence of vitamin D deficiency (time frame: Between the 1th and the 36th week of pregnancy). 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 NCT02904720, 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 19 Sep 2016.