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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190396
• Other study ID #: VIT D PLACENTAL CALCIFICATION
• Status: Completed
• Phase: N/A
• First received: June 21, 2014
• Last updated: July 12, 2014
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Term pregnancy

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Calcinosis
• Vitamin D Deficiency

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with low birth weight.		Three months	No
Secondary	Percentage of delivery with cesarean section.		Three months	No