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

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ClinicalTrials.gov Identifier: NCT02190396
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Ali Ozgur Ersoy, Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Condition or disease
Vitamin D Deficiency

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 .

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
Group 1
Placental calcification of Grade 3
Group 2
No placental calcification noted, the control group.



Primary Outcome Measures :
  1. Number of participants with low birth weight. [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Percentage of delivery with cesarean section. [ Time Frame: Three months ]

Biospecimen Retention:   None Retained
Maternal venous and umbilical cordon blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.
Criteria

Inclusion Criteria:

  • Term pregnancy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190396


Locations
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Turkey
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
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Principal Investigator: Ali O Ersoy Medical doctor
Publications:
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Responsible Party: Ali Ozgur Ersoy, Medical Doctor, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02190396    
Other Study ID Numbers: VIT D PLACENTAL CALCIFICATION
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by Ali Ozgur Ersoy, Zekai Tahir Burak Women's Health Research and Education Hospital:
Calcium
Vitamin D
Placental calcification.
Additional relevant MeSH terms:
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Vitamin D Deficiency
Calcinosis
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Metabolism Disorders
Metabolic Diseases