Symptoms and General Pathology

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Polycystic Ovary Syndrome

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Female Urogenital Diseases and Pregnancy Complications

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Bone Density Conservation Agents

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Vitamin D

Cholecalciferol

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Calcium, Dietary

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Trace Elements

Antacids

Anti-Ulcer Agents

Vitamin D3

Calciferol

40 female patients with PCO and 50 healthy women matched to PCOS women as regard age and ethnic origin.

42,000 IU oral vitamin D per week and 500 mg calcium carbonate

cholecalciferol (vit D3)

Polycystic ovary syndrome (PCOS) is a heterogeneous disorder of reproductive, endocrine and metabolic functions. Vitamin D has an influence on metabolic and reproductive functions. This study was designed to explore the levels of free 25 hydroxy cholecalciferol \[25(OH) D\] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation on cardiometabolic status, androgen profile and clinical features of PCOS.

Background Polycystic ovarian syndrome (PCOS) is a heterogeneous disorder affecting 510% of women of reproductive age. It is a disorder that affects the reproductive, endocrine and metabolic functions and is the leading cause of chronic anovulation leading to infertility.

PCOS is characterized by hyperandrogenism, chronic oligo or anovulation, and polycystic ovaries. Hyperandrogenism, in particular, is a hallmark feature of PCOS because it is strongly implicated in the genesis of the disorder; and is also associated with metabolic derangements that contribute to the underlying pathophysiology. Also, it is associated with cardiovascular risk factors including obesity, insulin resistance (IR), dyslipidemia, endothelial dysfunction, and metabolic syndrome.

Vitamin D (VD) is a fat-soluble vitamin that is naturally present in very few foods and available as a dietary supplement. It is a steroid hormone with pleiotropic effects. In addition to the main effects of VD on bone and calcium metabolism, it has other roles in the body, including modulation of cell growth, neuromuscular and immune function, and reduction of inflammation.

VD deficiency is now recognized as pandemic disease. Its prevalence varies according to geographic location, season, ethnicity and the standard laboratory value; of what is considered normal, deficient and insufficient. VD deficiency is a risk factor for hypertension, diabetes, and various cancers . Accumulating evidence suggests that VD deficiency might be a causal factor in the pathogenesis of IR and the metabolic syndrome in PCOS. Carotid intima-media thickness (CIMT) measured by ultrasound is a noninvasive, safe, low-cost, reproducible, and well-validated marker of preclinical atherosclerosis.

PCOS is the most frequent endocrine disorder among women of reproductive age and VD deficiency is a key problem in PCOS patients conversely, the basic mechanisms underlying the favorable effects of vitamin D in PCOS are still obscure. Resolving this mechanism may provide insight into the pathophysiology of this syndrome. It can also offer a new therapeutic option for PCOS women. Thus, in the present study was designed to explore the levels of free 25 hydroxyvitamin D \[25(OH) D\] in PCOS patients. We also aimed to clarify the impact of vitamin D supplementation cardiometabolic status, androgen profile and clinical features of PCOS. Methods This placebo-controlled trial comprised 95 women with PCO recruited from Outpatient Clinics of the Endocrinology Unit of Internal Medicine and Obstetrics and Gynecology Departments, Faculty of Medicine, Zagazig University, Egypt and 50 healthy women matched to PCOS women as regard age and ethnic origin. The diagnosis of PCOS was based on the 2004 revised Rotterdam criteria .. All women underwent the menstrual history and thorough clinical examination. All patients were assessed at the study start on the third day of a spontaneous or progesterone-induced menstrual cycle. Anthropometric measures were estimated, including waist/hip ratio, height and weight then we calculated body mass index (BMI). We estimated the hirsutism score according to Ferriman and Gallwey. .Ovarian volume and antral follicular count (AFC) were evaluated by transvaginal ultrasound (TVS). PCOS patients were randomized divided to the intervention group (n=55) received vitamin D supplements (42,000 IU oral vitamin D per week and 500 mg calcium carbonate per day for 12-week), and non-intervention group (n=40) received 500 mg calcium carbonate per day for 12-week. The exclusion criteria for all women included a history of hyperandrogenic states (such as nonclassic congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, 21-hydroxylase deficiency, or hyperprolactinemia), DM, hypertension, liver, kidney, or thyroid diseases. In addition, subjects on non-steroidal anti-inflammatory drugs and multivitamin, as well as patients treated with hormone replacement therapy. At the start of the study, the participants were asked to maintain their usual diet and level of physical activity throughout the study period as well as not to receive any lipid-lowering medications and medications that might affect their reproductive physiology during the 12-week intervention. At baseline and at the endpoint of the 12 weeks of study, anthropometrical measurements were estimated as well as and blood samples were collected for biochemical analyses. Written informed consent was taken from all of the participants after explaining details and benefits as well as risks to them. The ethical committee of the Faculty of Medicine, Zagazig University approved our study protocol.

2.1. Sampling of blood Blood samples were drawn from all subjects during the early follicular phase of the menstrual cycles. One ml was collected into tubes containing fluoride for fasting plasma glucose (FPG). A second remaining part underwent immediate serum separation and was stored at -20 ◦C until analysis serum. calcium, phosphate, albumin were measured. Total cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides levels were determined using routine enzymatic methods (Spinreact, Girona, Spain). Low-density lipoprotein (LDL) cholesterol levels were calculated using the Friedewald formula.

2.2. Immunochemical assays: We measured prolactin, FSH, and LH levels via chemiluminescence immunoassays (CLIA) provided by (Immunospec Corporation, CA, USA). Serum high-sensitivity C-reactive protein (hs-CRP) concentrations were measured using high sensitivity enzyme-linked immunosorbent assays (ELISA) (Biosource, Nivelles, Belgium). We determined to fast insulin, FSH, LH, total and free testosterone, sex hormone-binding globulin (SHBG) levels using ELISA kits (DRG International, USA). We calculated insulin resistance (IR) with the homeostatic model assessment (HOMA-IR) index, which is defined as fasting serum insulin (FSI) value (µU/ml) × fasting plasma glucose value (mg/dl)/405. The B cell function was calculated using HOMA- B as (20× (fasting insulin µU/mL)/ (fasting glucose (mmol/l) - 3.5).

2.3.Determination of serum vitamin D levels Serum concentrations of 25(OH)-D were tested using enzyme-linked immunosorbent assay, \[Cat No. EQ 6411-9601, Euroimmun Medizinische Labordiagnostika AG, Germany\]. Current recommendations define VD deficiency as serum 25(OH)-D levels less than 20 ng/ml and VD insufficiency less than 30 ng/ml.

2.4. Carotid ultrasonography Carotid artery atherosclerosis was determined by one examiner for all patients across all six sites, using high-resolution B-mode ultrasound (M-Turbo®, SonoSite, Washington, Bothell, USA), according to American Society of Echocardiography protocol.

Impact of Vitamin D Supplementation on Cardiometabolic Status and Androgen Profile in Polycystic Ovary Syndrome

Impact of Vitamin D Supplementation on the Cardiometabolic Status and Androgen Profile in Women With Polycystic Ovary Syndrome: Placebo-Controlled Clinical Trial

change of LDL (mg/dl), TG (mg/dl) TG (mg/dl) ,(mg/dl)

Ovarian volume cm were evaluated by transvaginal ultrasound

Serum concentrations of 25(OH)-D( ng/ml )

antral follicular count were evaluated by transvaginal ultrasound

Zagazig University

ass.professor of internal medicine

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

Both Extremities of Patients With Breast Cancer Related Lymphedema

Both Extremities of Healthy People With No History of Breast Cancer

We evaluated the both upper extremities of the patient and control group with elastography and B mode ultrasonography. Shear wave elastography evaluates tissue deformation caused by acoustic radiation force. A highly focused ultrasound radiation is produced; The propagation speed of the shear wave depends on the stiffness of the tissue. It is a simple, inexpensive, bedside, widely available, non-invasive technique. B mode USG can be used to assess skin and subcutaneous tissue thickness and echogenicity. Skin and subcutaneous thickness were measured with b mode ultrasound. Skin and subcutaneous tissue stiffness was measured by shear wave ultrasonography

Shear Wave Elastography and B Mode Ultrasonography

Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. In the questionnaire, the difficulties of the patients during their daily living activities are questioned with 11 questions. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.

Quick Dash Questionnare

The Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 functional subgroups. Each question is scored from 1 to 5, with higher scores indicating increased seriousness.

The Lymphedema Life Impact Scale

Arm pain and feeling of tension, heaviness and stiffness in the arm were evaluated separately by numerical scale. This scale is a 10 cm ruler that writes no pain, no tension, no heaviness, no stiffness on one side, and unbearable pain, tension and heaviness on the other side. Patients were asked to rate their associated symptoms on this scale between 0 and 10.

Questioning lymphedema-related symptoms

For the diagnosis of lymphedema, a detailed physical examination and extremity circumference were measured. This measurement was taken from both wrists to arm height with 4 cm intervals. Those with a circumference difference greater than 2 cm and/or no 10% volume difference were considered preclinical (latent) and those with clinical lymphedema.

Extremity circumference and volume measurement

CANAN ŞANAL TOPRAK

The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.

Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data

Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG

Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography

Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG

It is the relationship between the parameters evaluated by USG ( thickness in milimetres echogenity according to grading system) and SWE (stiffness in kilopascal) and the pain, tension, heaviness and stiffness scoring in which symptoms in numeric scale.

It is the relationship between the parameters evaluated by USG (thickhickness in milimetres , echogenity according to grading system) and SWE (stiffness in kilopascal) and QUİCK DASH Questionnaire Score

It is the relationship between the parameters evaluated by USG (thickness in milimetres ,echogenity according to grading system) and SWE (stiffness in kilopascal) and The Life İmpact Questionnaire Scale

It is the volume measurement of both arms of the patients in cubic centimetre.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Vitamin D Supplementation on Cardiometabolic Status and Androgen Profile in Polycystic Ovary Syndrome	NCT04117750	Evaluations, Di... Treatment Adher...	cholecalciferol...	20 Years - 33 Years	Zagazig University
Impact of Vitamin D Supplementation on Cardiometabolic Status and Androgen Profile in Polycystic Ovary Syndrome	NCT04117750	Evaluations, Di... Treatment Adher...	cholecalciferol...	20 Years - 33 Years	Zagazig University
Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema	NCT06009666	Lymphedema of U... Stiffness of Ha... Evaluations, Di...	Shear Wave Elas... Quick Dash Ques... The Lymphedema ... Questioning lym... Extremity circu...	18 Years - 75 Years	Marmara University
Impact of Vitamin D Supplementation on Cardiometabolic Status and Androgen Profile in Polycystic Ovary Syndrome	NCT04117750	Evaluations, Di... Treatment Adher...	cholecalciferol...	20 Years - 33 Years	Zagazig University

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