Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?
1 other identifier
observational
60
1 country
1
Brief Summary
Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at placental pathologies is unknown. Placental calcification is usually thought to be a physiological aging process. Nevertheless, it can be a pathological change resulting from the effects of environmental factors on the placenta. The aim of the investigators study was to evaluate the relationship between placental calcification and maternal and cord blood 25-hydroxyvitamin-D3 \[25(OH)D\] and calcium concentrations in low-risk obstetric population at term and their consequences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 21, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedJuly 15, 2014
July 1, 2014
2 months
June 21, 2014
July 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with low birth weight.
Three months
Secondary Outcomes (1)
Percentage of delivery with cesarean section.
Three months
Study Arms (2)
Group 1
Placental calcification of Grade 3
Group 2
No placental calcification noted, the control group.
Eligibility Criteria
Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.
You may qualify if:
- Term pregnancy
You may not qualify if:
- Foreknown systemic diseases, multiple pregnancy, smoking cigarettes, receiving vitamin D or calcium supplementation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Ankara, Turkey (Türkiye)
Related Publications (3)
Wuertz C, Gilbert P, Baier W, Kunz C. Cross-sectional study of factors that influence the 25-hydroxyvitamin D status in pregnant women and in cord blood in Germany. Br J Nutr. 2013 Nov;110(10):1895-902. doi: 10.1017/S0007114513001438. Epub 2013 May 23.
PMID: 23697742BACKGROUNDCho GJ, Hong SC, Oh MJ, Kim HJ. Vitamin D deficiency in gestational diabetes mellitus and the role of the placenta. Am J Obstet Gynecol. 2013 Dec;209(6):560.e1-8. doi: 10.1016/j.ajog.2013.08.015. Epub 2013 Aug 14.
PMID: 23954530BACKGROUNDSaffery R, Ellis J, Morley R. A convergent model for placental dysfunction encompassing combined sub-optimal one-carbon donor and vitamin D bioavailability. Med Hypotheses. 2009 Dec;73(6):1023-8. doi: 10.1016/j.mehy.2009.03.057. Epub 2009 Oct 9.
PMID: 19819084BACKGROUND
Biospecimen
Maternal venous and umbilical cordon blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali O Ersoy
Medical doctor
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
June 21, 2014
First Posted
July 15, 2014
Study Start
March 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
July 15, 2014
Record last verified: 2014-07