Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?

NCT ID: NCT02190396

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-05-31

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.

Detailed Description

Vitamin D deficiency is a public health problem prevalent throughout the World. Low blood 25-hydroxyvitamin D3 ( 25OHD ) level was found to be associated with preeclampsia, gestational diabetes, infectious diseases, decrease in fetal bone mineralization, and increase in fetal respiratory infections and infant wheezing [1].

Requirement of vitamin D is primarily met by the exposure of skin to sun and secondarily by intake of food. The provision of vitamin D from the skin depends upon melanin pigment, the use of sun screens, age, dressing style and seasonal changes [1]. Placenta plays an important role in Vitamin D metabolism during pregnancy and some independent risk factors increasing the risk of placental dysfunction at fetomaternal interface also influence vitamin D metabolism [2,3]. Nevertheless, there can be a pathological change resulting from the effects of environmental factors on the placenta .

Conditions

Vitamin D Deficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Placental calcification of Grade 3

No interventions assigned to this group

Group 2

No placental calcification noted, the control group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Term pregnancy

Exclusion Criteria

• Foreknown systemic diseases, multiple pregnancy, smoking cigarettes, receiving vitamin D or calcium supplementation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ali Ozgur Ersoy

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali O Ersoy

Role: PRINCIPAL_INVESTIGATOR

Medical doctor

Locations

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 23697742 (View on PubMed)

Cho 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.

Reference Type: BACKGROUND

PMID: 23954530 (View on PubMed)

Saffery 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.

Reference Type: BACKGROUND

PMID: 19819084 (View on PubMed)

Other Identifiers

VIT D PLACENTAL CALCIFICATION

Identifier Type: -

Identifier Source: org_study_id