The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome; Hypovitaminosis D
MeSH terms: Polycystic Ovary Syndrome; Rickets; Overweight; Avitaminosis; Vitamin D Deficiency; Syndrome
Intervention: 50,000 IU vitamin D3; Placebo
Intervention description: Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU; Placebo film-coated tablet of Biodal 50,000 IU
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vitamin D; deficiency; hypovitaminosis D; Biodal; 25 hydroxy Vitamin D; 25hydroxyvitamin D; 25(OH)D; PCOS; insulin resistance; BMI; chromium levels; vitamin D 3; cholecalciferol; 50,000 IU

Summary:

      This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial
      designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on
      Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum
      chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian
      female patients diagnosed with PCOS and with hypovitaminosis D.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female gender.

          -  Aged between 18 and 49 years old.

          -  Ethnic group (Caucasian, Middle-eastern).

          -  Overweight (BMI 25-30 kg^m2).

          -  Diagnosed with Polycystic ovary syndrome according to Rotterdam criteria (Rotterdam
             SHRE-ASRM Sponsored Polycystic ovary syndrome consensus workshop group, 2004).

          -  Diagnosed with hypovitaminosis D (serum 25(OH)D level < 20 ng/mL).

          -  Inadequate dietary intake of vitamin D (<600 IU/day or <15μg/day).

          -  Physical examination being assessed and accepted by the attending physician.

          -  Systolic blood pressure within the normal range (90-140 mmHg).

          -  Diastolic blood pressure within the normal range (60-90 mmHg).

          -  Heart rate within the normal range (60-100 BPM).

          -  Oral body temperature within the normal range (35.9 - 37.6 Cᵒ).

          -  Normal complete blood count , Liver Function enzymes test , Aspartate Transaminase
             (AST) , Alanine Transaminase (ALT) and Kidney function tests , Blood Urea Nitrogen
             (BUN) and Serum Creatinine (SrCr).

          -  Participant is willing and able to give informed consent for participation in the
             study.

          -  Able and willing to comply with all study requirements.

        Exclusion Criteria:

          -  Female participants who are pregnant, lactating or planning pregnancy during the
             course of the study.

          -  Ethnic group: non Caucasian.

          -  Females aged <18 or >49 years old.

          -  Underweight, normal body weight ,Body Mass Index (BMI) < 25 kg^m2

          -  Obese or morbidly obese (BMI > 30 kg/m2)

          -  Diagnosis with type 1 or type 2 diabetes mellitus, hypothyroidism, hyperthyroidism,
             liver disease, renal dysfunction, cardiovascular diseases, androgen-secreting tumor,
             Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia, and/or virilism.

          -  Known history or presence of food allergies or intolerance (e.g dairy products or
             gluten-containing foods), or any known condition that could interfere with the
             absorption, distribution, metabolism, or excretion of drugs.

          -  History of drug or alcohol abuse, smoking of 10 cigarettes or more (or equivalent) per
             day.

          -  Participants who took medications known to affect metabolic parameters, such as
             metformin and corticosteroid drugs, vitamin D and calcium.

          -  Adequate dietary intake of vitamin D (600 IU/day or 15μg/day or more).

          -  Participation in another clinical or bioequivalence study within 90 days prior to the
             start of this study period.

          -  Participants with abnormal Electrocardiogram (ECG).

          -  Participants with any abnormal laboratory results excluding [ 25(OH)D, Creatinine
             (Cr), Calcium (Ca), phosphorus (PO4), C-reactive protein(CRP) , triglyceride , High
             Density Lipoprotien Cholesterol (HDL-C), Low Density Lipoprotien Cholesterol (LDL-C),
             total cholesterol (TC)/HDL-C ratio, fasting insulin , fasting blood glucose, oral
             glucose tolerance test, impaired glucose tolerance, Progesterone, total testosterone,
             sex hormone binding globulin, parathyroid hormone and free androgen index].