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Assesment of Vit D3 Level in Cases of Unexplaind Pregnancy Loss in Assiut (vitDinRPL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327766
Recruitment Status : Unknown
Verified October 2017 by Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt

Brief Summary:
Assesment of Vit D3 leve in cases of unexplained recurrent pregnancy loss in assiut

Condition or disease Intervention/treatment
vitD3 Level in Cases of Recuurent Pregnancy Loss Diagnostic Test: 4-Measurment of serum 25(OH)D3 using Vidas by ELFA meathod.

Detailed Description:

Recurrent pregnancy loss is defined as two or more consecutive pregnancy loss before 20 weekse of gestation (1). It affects about 1-5% of women of reproductive age. This not only causes significant physical and mental problems in families, but also a heavy economic burden on families and health systems (2, 3) Recurrent pregnancy loss (RPL) is a syndrome caused by multiple etiologies such as anatomical, endocrine, genetic, infectious, immunological, thrombotic and unexplained etiologies hence an investigation of underlying etiologies is often complicated When the conventional investigation scheme is applied, up to 60% of women with RPL remain unexplained (4). Recent studies have indicated that immune inflammatory and thrombotic conditions are two major under-lying pathologies for RPL (5). Approximately 20% of women with RPL have autoimmune conditions, such as antiphospholipid antibody (APA)(6),antinuclear antibody (ANA), anti-thyroperoxidase antibody and anti-thyroglobulin antibody(7,8).

Immune function in pregnancy From initial implantation of the conceptus, the maternal uterine endometrium undergoes decidualisation to support placental development and function. The resulting decidua is a tissue formed from the maternal endometrium, originating from epithelial and stromal cells, and is characterised by invasion from the extraembryonic fetal-derived trophoblasts and close 'cell-cell juxtaposition' of these different tissues The principal function of the decidua is to facilitate early fetal-maternal exchange of nutrients, gases and waste, while also acting as a secretory source of steroid hormones, cytokines and growth factors (9).However, the decidua also plays a key role in protecting pregnancy against maternal immune surveillance(10) .

Cellular infiltration is a key feature of immune function within decidua, and leukocytes comprise at least 40% of the total decidual stromal cell population(11) . The leukocyte subtypes present include decidual (uterine) natural killer (uNK) cells, macrophage subtypes, CD4C and CD8C T-lymphocytes (including T-regulatory cells (Tregs) and antigen-presenting cells (APCs) such as dendritic cells (DCs)(12) . There has been renewed interest in the role vitamin D, as key regulators of decidual immune cell function and its roles in fetal-maternal immune tolerance (13) .

- 3 - Vitamin D and autoimmunity Vitamin D, a steroid hormone, is well known to be involved in calcium and phosphate homeostasis and bone metabolism (14).The target organs for the non-classical actions of the vitamin D include immune systems, pancreatic b-cells, the heart and cardiovascular system, the brain and reproductive tissues. Tissue responses to vitamin D include regulation of hormone secretion modulation of immune responses, and a control of cellular proliferation and differentiation (15). Vitamin D was also reported to inhibit proliferation of T helper 1 (Th1) cells and limit their production of cytokines, such as interferon gamma (IFN-g), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-a).Conversely, vitamin D induces T helper 2 (Th2) cytokines, such as IL-4, IL-5, IL-6, IL-9, IL-10 and IL-13 (16). Furthermore, in many studies vitamin D has been presented as a modifiable environmental factor for Th1-mediated autoimmune disease and appears to be important for susceptibility to and severity of the disease (17). Vitamin D also regulates B cell immunity. It down-regulates the proliferation and differentiation of B lymphocytes and inhibits IgG production (16).

Vitamin D deficiency in pregnant women is associated with increased risk of obstetrical complications such as pre-eclampsia (18), bacterial vaginosis associated preterm delivery (19), gestational diabetes mellitus (20) and small-for-gestational age births (21).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assesment of Vit D3 Level in Cases of Unexplaind Pregnancy Loss in Assiut
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
RPL group
history of unexplained recurrent pregnancy loss (defined as two or more consecutive missed miscarriage before 14 weeks of gestation).
Diagnostic Test: 4-Measurment of serum 25(OH)D3 using Vidas by ELFA meathod.
A specialized test of the 25(OH)D serum level was conducted and the blood samples were collected in the months of November to April. The winter months were chosen intentionally in order to limit the impact of the sun light upon 25(OH)D serum level.The test VIDAS® 25 OH Vitamin D Total was used-enzyme immunoassay with highly fluorescent measurement ELFA. According to the reference values of this method the 25(OH)D < 20 ng/ml serum levels are considered as deficiency and the serum levels between 20 - 30ng/ml are defined as insufficiency. It's sufficient if the level of 25(OH)D is 30 to 100 ng/ml.

Control group
womens coming for contraception after normal pregnancy outcome.
Diagnostic Test: 4-Measurment of serum 25(OH)D3 using Vidas by ELFA meathod.
A specialized test of the 25(OH)D serum level was conducted and the blood samples were collected in the months of November to April. The winter months were chosen intentionally in order to limit the impact of the sun light upon 25(OH)D serum level.The test VIDAS® 25 OH Vitamin D Total was used-enzyme immunoassay with highly fluorescent measurement ELFA. According to the reference values of this method the 25(OH)D < 20 ng/ml serum levels are considered as deficiency and the serum levels between 20 - 30ng/ml are defined as insufficiency. It's sufficient if the level of 25(OH)D is 30 to 100 ng/ml.




Primary Outcome Measures :
  1. vitamin D level [ Time Frame: 1 year ]
    the serum level of will be checked in ng/ml


Biospecimen Retention:   Samples Without DNA
serum samples from both cases and control groups will be stored at -20 degrees


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

50 womens with history of RPL in last 2 pregnanses and last abortion of 6 months at El-mabra H. & AUH.

50 womens coming for contraception after normal pregnancy outcome. As acotrol group.

Criteria

Inclusion Criteria:

  1. Age of women 20:35years old
  2. history of unexplained recurrent pregnancy loss (defined as two or more consecutive missed miscarriage before 14 weeks of gestation).

Exclusion Criteria:

  1. Un corrected uterine anomalies.
  2. Uncontrolled DM .
  3. Systemic disease(SLE,Rheumatoid arthritis).
  4. Thyroid dysfunction.
  5. Antiphospholipid antibody syndrome
  6. Cervical incompetence

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): NCT03327766


Contacts
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Contact: hisham abou-taleb, MD PhD 01003332139 hishamaboutaleb1@yahoo.com
Contact: Asmaa Abozaid, MD 01069866191 asmaa.abouzaid1@yahoo.com

Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Study Director: Ezat Hamed Professor of obstetrics and gynecology Faculty of medicine-Assiut university
Publications:
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Responsible Party: Hisham Ahmed El-Sayed Abou-Taleb, lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT03327766    
Other Study ID Numbers: Vit D and RPL
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt:
vitamin D and recurrent pregnancy loss
Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Pregnancy Complications
Death
Pathologic Processes
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents