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Vitamin D3

Calciferol

50,000 IU Vitamin D3 tablet given orally once weekly for 3 months

Placebo tablet given orally once weekly for 3 months

Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU

50,000 IU vitamin D3

Placebo film-coated tablet of Biodal 50,000 IU

Placebo

ALA M ABU RUQAA, MSC PHARM

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.

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).

The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)

The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid

Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination.

In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic.

An improvement in PCOS prognosis clinically by ultrasound examination is defined by:

* decreasing the number of follicles to \< 12 follicles measuring 2-9 mm in diameter
* decreasing ovarian volume to \< 10 cm3

Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level \> 4 ng/mL.

One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity.

In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol.

The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated.

The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth).

In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms.

The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms.

The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level.

One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated.

Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment.

In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol.

One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms.

the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated.

Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG).

In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.

Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index.

One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated.

Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms.

One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration.

In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.

The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated.

Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D \> 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment .

In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.

Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be \> 0.05 and \< 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3.

In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.

One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated.

Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame.

In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.

One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI).

Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be \<25-30 kg/m\^2.

Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms.

In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months).

Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period.

In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.

Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.

In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.

Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.

In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.

Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment.

In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.

Jordan University of Science and Technology

Hayat Pharmaceutical Co. PLC

Vitamin D supplementation for vitamin D deficient (\<20 ng/ml) women with 50,000 IU/week for 12 weeks did not lead to any side effects.

50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route

50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months

Vitamin D3 (Biodal 50,000IU)

placebo coated tablet by oral route

placebo: placebo coated tablet by oral route

Placebo (Biodal 50,000IU Placebo tablets) coated tablets by oral route

Placebo: 50,000IU Vitamin D3 placebo (Biodal 50,000IU placebo) once weekly for 3 months

Placebo (Biodal 50,000IU Placebo)

Total

Age, Continuous

Sex: Female, Male

Jordan

Region of Enrollment

Both Overies are Normal

Left or Right is Normal

Both are Polycystic

Ultrasound Examination

The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).

Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth).

Hirsutism Score

25(OH)D Serum Level

Progesterone Serum Level

Total Testosteron Serum Level

Chromium Serum Level

Calcium Serum Level

Phosphorus Serum Level

Parathyroide Hormon Serum Level

LDLC

Total Cholestrol

Lipid Profile

This indicate the Total Cholesterol to High Density Lipoprotien ratio. An optimal ratio is between 3.5-to-1. A higher ratio means a higher risk of heart disease.

TC / HDL-C Ratio

Fasting Insulin Serum Level

Fasting Blood Sugar Serum Level

C-Reactive Protien Serum Level

Oral Glucose Tolerance Test (1st Hour)

Sex Hormon Binding Globulin

Body Mass Index

Regular

Irrigular

Menstrual Cycle Regularity

Number of participants in each arm had been randomly allocated.

* The study was conducted only in the north of Jordan
* Body composition was measured by bioelectrical impedance
* Insulin resistance was assessed using the indirect method of assessment (HOMA)
* The study was done exclusively on overweight women

DR. ALA' ABU RUQA'A

The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value\</= 0.05)

Both Normal

Left or Right Normal

Both Polycystic

Ultrasound Examination of Number of Follicles and Ovarian Volume

Both arms where evaluated at which paired t-test for the mean difference in the two arm was calculated . where the serum 25-OH Vit D3 was measured at 0 day time and after the end of the study. after that a paired t-test where applied for the difference for the 25-OH VitD3 levels between the two time points

Serum 25-Hydroxy Vitamin D3 Level

Serum Chromium Concentration

Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment

Placebo coated tablet by oral route

Placebo: placebo coated tablet by oral route

50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route

50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months

Serum Parathyroid Hormone Concentration

Irregular

50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route

50.000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months

Menstrual Regularity

Serum Calcium Concentration

Serum Phosphorous Concentration

placebo coated tablet by oral route

placebo (Biodal 50,000 IU): 50.000IU Vitamin D3 (Biodal 50.000IU ) placebo once weekly for 3 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)	NCT02328404	Polycystic Ovar... Hypovitaminosis...	50,000 IU vitam... Placebo	18 Years - 49 Years	Hayat Pharmaceutical Co. PLC
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)	NCT02328404	Polycystic Ovar... Hypovitaminosis...	50,000 IU vitam... Placebo	18 Years - 49 Years	Hayat Pharmaceutical Co. PLC
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)	NCT02328404	Polycystic Ovar... Hypovitaminosis...	50,000 IU vitam... Placebo	18 Years - 49 Years	Hayat Pharmaceutical Co. PLC
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)	NCT02328404	Polycystic Ovar... Hypovitaminosis...	50,000 IU vitam... Placebo	18 Years - 49 Years	Hayat Pharmaceutical Co. PLC

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