Correlation Between Vitamin D and B Regulatory Cell in Pregnancy

Labor, Premature Clinical Trial

Official title:

Correlation Between B Regulatory Cell and Vitamin D Status in Term and Preterm Labor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04105881
• Other study ID #: Dear
• Status: Not yet recruiting
• Start date: February 10, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Khalid Hassanein, Professor
• Phone: +20109191208
• Email: Khaledhassanein70[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.

Description:

During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.the fetus is normally accepted by the maternal immune system despite despite the expression of paternal alloantigens. Normally, the fetus grows and develops very well with ongoing pregnancy.

B regulatory cells are increased in pregnant women compared to non-pregnant women.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 15, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy female according to the required groups

Exclusion Criteria:

• patient with infectious disease , tuberculosis ,tumor ,hematologic disease,metabolic bone disease or any other connective tissue diseases were excluded.

• Patient with viral hepatitis.

• serological evidence of HIV infection.

Related Conditions & MeSH terms

• Labor, Premature
• Obstetric Labor, Premature

Intervention

Dietary Supplement:
• Investigation
Cross sectional intervention

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut
Egypt	Assiut university	Asyut	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Lima J, Martins C, Leandro MJ, Nunes G, Sousa MJ, Branco JC, Borrego LM. Characterization of B cells in healthy pregnant women from late pregnancy to post-partum: a prospective observational study. BMC Pregnancy Childbirth. 2016 Jun 6;16(1):139. doi: 10.1 — View Citation

Zahran AM, Zharan KM, Hetta HF. Significant correlation between regulatory T cells and vitamin D status in term and preterm labor. J Reprod Immunol. 2018 Sep;129:15-22. doi: 10.1016/j.jri.2018.07.004. Epub 2018 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in number of B regulatory cell in pregnant woman	Immune system immunosuppressed to maintain fetus	9 months