Trial Outcomes & Findings for The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS) (NCT NCT02328404)

Last Updated: 2016-08-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

3 months

Results posted on

2016-08-04

Participant Flow

Random sample of women attending outpatient obstetrics and gynecology clinics in King Abdullah Hospital / Jordan University of Science and Technology

Approximately 120 women will be assessed for eligibility clinically, anthropometrically, dietary and biochemically. Women diagnosed with PCOS and vitamin D deficiency will be randomly divided into 2 groups

Participant milestones

Participant milestones
Measure	Vitamin D3 (Biodal 50,000IU) 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	Placebo placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Overall Study STARTED	30	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo (Biodal 50,000IU Placebo) n=29 Participants 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	Total n=58 Participants Total of all reporting groups
Age, Continuous Age	23.56 years n=5 Participants	23.56 years n=7 Participants	23.56 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Jordan	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants
Ultrasound Examination Both Overies are Normal	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Ultrasound Examination Left or Right is Normal	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Ultrasound Examination Both are Polycystic	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants
Hirsutism Score	16.5 units on a scale STANDARD_DEVIATION 0.86 • n=5 Participants	16.8 units on a scale STANDARD_DEVIATION 1.19 • n=7 Participants	16.65 units on a scale STANDARD_DEVIATION 1.025 • n=5 Participants
25(OH)D Serum Level	12.46 ng/ml STANDARD_DEVIATION 3.29 • n=5 Participants	12.37 ng/ml STANDARD_DEVIATION 2.91 • n=7 Participants	12.415 ng/ml STANDARD_DEVIATION 3.08 • n=5 Participants
Progesterone Serum Level	5.2 nmol/L STANDARD_DEVIATION 1.86 • n=5 Participants	10.7 nmol/L STANDARD_DEVIATION 3.48 • n=7 Participants	7.7 nmol/L STANDARD_DEVIATION 2.67 • n=5 Participants
Total Testosteron Serum Level	2.1 nmol/L STANDARD_DEVIATION 0.17 • n=5 Participants	1.8 nmol/L STANDARD_DEVIATION 0.15 • n=7 Participants	1.95 nmol/L STANDARD_DEVIATION 0.16 • n=5 Participants
Chromium Serum Level	0.29 ppm STANDARD_DEVIATION 0.01 • n=5 Participants	0.30 ppm STANDARD_DEVIATION 0.01 • n=7 Participants	0.295 ppm STANDARD_DEVIATION 0.01 • n=5 Participants
Calcium Serum Level	2.3 mmol/L STANDARD_DEVIATION 0.02 • n=5 Participants	2.3 mmol/L STANDARD_DEVIATION 0.02 • n=7 Participants	2.3 mmol/L STANDARD_DEVIATION 0.02 • n=5 Participants
Phosphorus Serum Level	1.1 nmol/L STANDARD_DEVIATION 0.03 • n=5 Participants	1.1 nmol/L STANDARD_DEVIATION 0.02 • n=7 Participants	1.1 nmol/L STANDARD_DEVIATION 0.03 • n=5 Participants
Parathyroide Hormon Serum Level	65.3 Pg/ml STANDARD_DEVIATION 5.91 • n=5 Participants	61.8 Pg/ml STANDARD_DEVIATION 4.54 • n=7 Participants	63.55 Pg/ml STANDARD_DEVIATION 5.225 • n=5 Participants
Lipid Profile LDLC	3.3 mmol/L STANDARD_DEVIATION 0.15 • n=5 Participants	3.4 mmol/L STANDARD_DEVIATION 0.19 • n=7 Participants	3.35 mmol/L STANDARD_DEVIATION 0.17 • n=5 Participants
Lipid Profile HDL	1.3 mmol/L STANDARD_DEVIATION 0.06 • n=5 Participants	1.3 mmol/L STANDARD_DEVIATION 0.04 • n=7 Participants	1.3 mmol/L STANDARD_DEVIATION 0.05 • n=5 Participants
Lipid Profile Total Cholestrol	5.3 mmol/L STANDARD_DEVIATION 0.20 • n=5 Participants	5.3 mmol/L STANDARD_DEVIATION 0.26 • n=7 Participants	5.3 mmol/L STANDARD_DEVIATION 0.23 • n=5 Participants
TC / HDL-C Ratio	4.3 Ratio STANDARD_DEVIATION 0.20 • n=5 Participants	4.5 Ratio STANDARD_DEVIATION 0.26 • n=7 Participants	4.4 Ratio STANDARD_DEVIATION 0.23 • n=5 Participants
Fasting Insulin Serum Level	10.2 uU/ml STANDARD_DEVIATION 1.23 • n=5 Participants	9.8 uU/ml STANDARD_DEVIATION 2.17 • n=7 Participants	10.0 uU/ml STANDARD_DEVIATION 3.4 • n=5 Participants
Fasting Blood Sugar Serum Level	4.7 mmol/L STANDARD_DEVIATION 0.07 • n=5 Participants	4.9 mmol/L STANDARD_DEVIATION 0.07 • n=7 Participants	4.83 mmol/L STANDARD_DEVIATION 0.04 • n=5 Participants
C-Reactive Protien Serum Level	6.6 mg/L STANDARD_DEVIATION 1.13 • n=5 Participants	3.7 mg/L STANDARD_DEVIATION 0.69 • n=7 Participants	5.15 mg/L STANDARD_DEVIATION 0.91 • n=5 Participants
Oral Glucose Tolerance Test (1st Hour)	7.4 mmol/L STANDARD_DEVIATION 0.33 • n=5 Participants	7.7 mmol/L STANDARD_DEVIATION 0.48 • n=7 Participants	7.55 mmol/L STANDARD_DEVIATION 0.41 • n=5 Participants
Sex Hormon Binding Globulin	57.9 nmol/L STANDARD_DEVIATION 9.29 • n=5 Participants	111.2 nmol/L STANDARD_DEVIATION 16.7 • n=7 Participants	84.55 nmol/L STANDARD_DEVIATION 13.00 • n=5 Participants
Body Mass Index	27.33 kg/m^2 STANDARD_DEVIATION 0.16 • n=5 Participants	27.33 kg/m^2 STANDARD_DEVIATION 0.30 • n=7 Participants	27.33 kg/m^2 STANDARD_DEVIATION 0.23 • n=5 Participants
Menstrual Cycle Regularity Regular	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Menstrual Cycle Regularity Irrigular	26 participants n=5 Participants	25 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 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)

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Ultrasound Examination of Number of Follicles and Ovarian Volume Both Normal	7 participants	0 participants
Ultrasound Examination of Number of Follicles and Ovarian Volume Left or Right Normal	5 participants	11 participants
Ultrasound Examination of Number of Follicles and Ovarian Volume Both Polycystic	17 participants	18 participants

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Menstrual Regularity Regular	27 participants	4 participants
Menstrual Regularity Irregular	2 participants	25 participants

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Hirsutism Score	11.5 units on a scale Standard Error 0.93	16.7 units on a scale Standard Error 1.21

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum Progesterone Level	5.8 nmol/L Standard Error 1.86	7.3 nmol/L Standard Error 2.42

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Total Testosterone Level	1.6 nmol/L Standard Deviation 0.17	1.9 nmol/L Standard Deviation 0.1

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Free Androgen Index	4.5 Ratio Standard Deviation 0.93	4.4 Ratio Standard Deviation 1.10

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Sex Hormone Binding Globulin Concentration	85.9 nmol/L Standard Deviation 15.19	100.6 nmol/L Standard Deviation 15.8

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum 25-Hydroxy Vitamin D3 Level	48.2 ng/ml Standard Error 2.03	11.8 ng/ml Standard Error 0.76

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum Chromium Concentration	0.27 ppm Standard Error 0.01	0.27 ppm Standard Error 0.01

SECONDARY outcome

Timeframe: 3 months

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).

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment	6.9 mmol/L Standard Error 0.50	6.4 mmol/L Standard Error 0.54

SECONDARY outcome

Timeframe: 3 months

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).

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Body Mass Index	25.6 kg/m^2 Standard Error 0.37	26.5 kg/m^2 Standard Error 0.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum Parathyroid Hormone Concentration	39.1 Pg/ml Standard Error 2.60	52.6 Pg/ml Standard Error 4.18

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum Calcium Concentration	2.3 mmol/L Standard Error 0.02	2.3 mmol/L Standard Error 0.2

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum Phosphorous Concentration	1.2 mmol/L Standard Error 0.3	1.2 mmol/L Standard Error 0.2

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Vitamin D3 (Biodal 50,000IU) n=29 Participants 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	Placebo n=29 Participants placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Serum C-Reactive Protien Concentration	5.4 mg/L Standard Error 1.06	3.9 mg/L Standard Error 1.17

Adverse Events

Vitamin D3 (Biodal 50,000IU)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vitamin D3 (Biodal 50,000IU) n=30 participants at risk 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	Placebo n=30 participants at risk placebo coated tablet by oral route placebo: placebo coated tablet by oral route
Social circumstances In-compliance , Withdral	3.3% 1/30 • Number of events 1 • Baseline, 3 months 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.	3.3% 1/30 • Number of events 1 • Baseline, 3 months 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.

Additional Information

DR. ALA' ABU RUQA'A

Hayat Pharmaceutical industries

Phone: 00962 6 4162607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place