Clinical trial NCT02328404: The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
Official title: The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Hypovitaminosis D
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
Lead sponsor: Hayat Pharmaceutical Co. PLC
Sponsor class: INDUSTRY
Collaborators: name: Jordan University of Science and Technology
First posted: 2014-12-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study is designed to assess the safety and efficacy of 50,000 IU vitamin D supplementation once weekly for 3 months on improvement in PCOS prognosis and improvement in serum 25(OH)D levels in 60 overweight Jordanian females (defined as having a BMI 25-30kg/m2), diagnosed with PCOS (based on Rotterdam criteria), and with hypovitaminosis D (defined as a serum 25(OH)D level \< 20 ng/mL), compared with placebo.

Evaluation of the safety and efficacy of the dosing regimen will be conducted over 6 study visits during which clinical and biochemical signs of PCOS as well as serum 25(OH)D level, serum chromium level, insulin resistance, and BMI will be evaluated.

The measurements will be collected as follows : day (-7) during screening , Day (0) base line measurements , Day (30) , Day(60), Day (90), day (104).

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 \[ 25(OH)D, Creatinine (Cr), Calcium (Ca), phosphorus (PO4), C-reactive protein(CRP) , triglyceride , High Density Lipoprotien Cholesterol (HDL-C), Low Density Lipoprotien Cholesterol (LDL-C), total cholesterol (TC)/HDL-C ratio, fasting insulin , fasting blood glucose, oral glucose tolerance test, impaired glucose tolerance, Progesterone, total testosterone, sex hormone binding globulin, parathyroid hormone and free androgen index\].

Primary outcomes:
measure: Ultrasound Examination of Number of Follicles and Ovarian Volume
timeFrame: 3 months
measure: Menstrual Regularity
timeFrame: 3 months
measure: Hirsutism Score
timeFrame: 3 months
measure: Serum Progesterone Level
timeFrame: 3 months
measure: Total Testosterone Level
timeFrame: 3 months
measure: Free Androgen Index
timeFrame: 3 months
measure: Sex Hormone Binding Globulin Concentration
timeFrame: 3 months
Secondary outcomes:
measure: Serum 25-Hydroxy Vitamin D3 Level
timeFrame: 3 months
measure: Serum Chromium Concentration
timeFrame: 3 months
measure: Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment
timeFrame: 3 months
measure: Body Mass Index
timeFrame: 3 months
measure: Serum Parathyroid Hormone Concentration
timeFrame: 3 months
measure: Serum Calcium Concentration
timeFrame: 3 months
measure: Serum Phosphorous Concentration
timeFrame: 3 months
measure: Serum C-Reactive Protien Concentration
timeFrame: 3 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
Study officials:
affiliation: HAYAT PHARMACEUTICAL INDUSTRIES CO. PLC
name: ALA M ABU RUQAA, MSC PHARM
role: STUDY_DIRECTOR
References:
citation: Al-Bayyari N, Al-Domi H, Zayed F, Hailat R, Eaton A. Androgens and hirsutism score of overweight women with polycystic ovary syndrome improved after vitamin D treatment: A randomized placebo controlled clinical trial. Clin Nutr. 2021 Mar;40(3):870-878. doi: 10.1016/j.clnu.2020.09.024. Epub 2020 Sep 24.