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Plasma Concentrations of Calcium, Phosphate, FGF23, Klotho, 25 (OH) D3 and 1,25 (OH) 2D3 From Patients Who Wants to Have Children

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ClinicalTrials.gov Identifier: NCT03173235
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Women's Hospital Tübingen

Brief Summary:
1,25-dihydroxy-vitamin D3 (1,25 (OH) 2D3) or calcitriol regulates plasma calcium and phosphate concentrations in the blood by stimulating intestinal absorption and renal reabsorption of calcium and phosphate. 1.25 (OH) 2D3 is formed by the renal 1α25OH vitamin D-hydroxylase (Cyp27b1) and inactivated by the renal 25-hydroxy vitamin D-24-hydroxylase (Cyp24). Unpublished studies in mice revealed an inhibitory effect of 1.25 (OH) 2D3 on embryo implanation. An excess of 1.25 (OH) 2D3 could therefore lead to female infertility. The excess of 1.25 (OH) 2D3 could result from uncritical vitamin D intake with insufficient negative feedback by FGF23 / Klotho. The aim of the study is to identify patients with an excess of 1.25 (OH) 2D3.

Condition or disease Intervention/treatment
Infertility, Female Diagnostic Test: Plasma level of vitamin D

Detailed Description:
The physiological institute of the University Tübinge has succeeded in preventing vascular calcification in Klotho-deficient mice by inhibiting osteogenic signal transduction. The animals reach an almost normal life span despite increased 1.25 (OH) 2D3, Ca2 + and phosphate plasma concentrations. The male animals are again fertilized, but not the female animals. However, if the plasma concentrations of 1.25 (OH) 2D3 are normalized by administration of a vitamin-poor diet, the female animals are fertilized within two weeks. Further investigations revealed an inhibitory effect of 1.25 (OH) 2D3 on the implantation of the embryo. In the meantime the 1,25 (OH) 2D3-dependent signal transduction could be revealed, which prevents the implantation of the embryo. The vitamin D receptor and the elements of signal transduction are also expressed in the human endometrium. It is therefore possible that increased 1.25 (OH) 2D3 plasma concentrations also prevent embryo implantation in humans.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Plasma Concentrations of Calcium, Phosphate, FGF23, Klotho, 25 (OH) D3 and 1,25 (OH) 2D3 From Patients Who Wants to Have Children
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Group/Cohort Intervention/treatment
Infertile women
Women which desire to have children but are probable infertile between 18 and 45 year old
Diagnostic Test: Plasma level of vitamin D
messurement of plasma level of vitamin D
healthy women
Healthy women without systemic diseases in the age of 18 to 45 years
Diagnostic Test: Plasma level of vitamin D
messurement of plasma level of vitamin D



Primary Outcome Measures :
  1. Plasma level of 25(OH)D3 and 1,25(OH)2D3 [ Time Frame: 1 day ]

Biospecimen Retention:   Samples With DNA
Blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women in the age of 18 to 45 years
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Known systemic diseases, e.g. Autoimmune disease, scleroderma, malignant disease

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): NCT03173235


Contacts
Contact: Melani Henes, Dr melanie.henes@med.uni-tuebingen.de

Locations
Germany
University Women's Hospital Recruiting
Tübingen, Germany, 72076
Contact: Miriam Linneweh, Dr    004970712985380    miriam.linneweh@med.uni-tuebingen.de   
Sponsors and Collaborators
University Women's Hospital Tübingen

Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT03173235     History of Changes
Other Study ID Numbers: Vitamin D
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility, Female
Infertility
Genital Diseases, Male
Genital Diseases, Female
Vitamins
Vitamin D
Calcifediol
Calcitriol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents