Trial · NCT02328404
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
NCT02328404, Phase 3, Completed, Hayat Pharmaceutical Co. PLC; results first posted 2015-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS). Trials, record NCT02328404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02328404
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
- NCT number
- NCT02328404
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Hayat Pharmaceutical Co. PLC
- Conditions
- Polycystic Ovary Syndrome, Hypovitaminosis D
- Interventions
- 50,000 IU vitamin D3, Placebo
- First posted
- 2014-12-31
- Last updated
- 2016-08-04
- Other registries' IDs
- eudract:2013-003353-22
- Results first posted
- 2015-04-17
- Limitations and caveats
* 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
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ultrasound Examination of Number of Follicles and Ovarian Volume | 3 months | 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 |
| Primary | Menstrual Regularity | 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. |
| Primary | Hirsutism Score | 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. |
| Primary | Serum Progesterone Level | 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. |
| Primary | Total Testosterone Level | 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. |
| Primary | Free Androgen Index | 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. |
| Primary | Sex Hormone Binding Globulin Concentration | 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. |
| Secondary | Serum 25-Hydroxy Vitamin D3 Level | 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. |
| Secondary | Serum Chromium Concentration | 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. |
| Secondary | Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment | 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ultrasound Examination of Number of Follicles and Ovarian Volume | 3 months | 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) | participants | NUMBER |
| SECONDARY | Serum 25-Hydroxy Vitamin D3 Level | 3 months | ng/ml | MEAN | |
| SECONDARY | Serum Chromium Concentration | 3 months | ppm | MEAN | |
| SECONDARY | Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment | 3 months | mmol/L | MEAN | |
| SECONDARY | Body Mass Index | 3 months | kg/m^2 | MEAN | |
| SECONDARY | Serum Parathyroid Hormone Concentration | 3 months | Pg/ml | MEAN | |
| PRIMARY | Menstrual Regularity | 3 months | participants | NUMBER | |
| SECONDARY | Serum Calcium Concentration | 3 months | mmol/L | MEAN | |
| SECONDARY | Serum Phosphorous Concentration | 3 months | mmol/L | MEAN | |
| PRIMARY | Hirsutism Score | 3 months | units on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ultrasound Examination of Number of Follicles and Ovarian Volume | Vitamin D3 (Biodal 50,000IU) | Both Normal | 7 | participants | |
| Ultrasound Examination of Number of Follicles and Ovarian Volume | Placebo | Both Normal | 0 | participants | |
| Ultrasound Examination of Number of Follicles and Ovarian Volume | Vitamin D3 (Biodal 50,000IU) | Left or Right Normal | 5 | participants | |
| Ultrasound Examination of Number of Follicles and Ovarian Volume | Placebo | Left or Right Normal | 11 | participants | |
| Ultrasound Examination of Number of Follicles and Ovarian Volume | Vitamin D3 (Biodal 50,000IU) | Both Polycystic | 17 | participants | |
| Ultrasound Examination of Number of Follicles and Ovarian Volume | Placebo | Both Polycystic | 18 | participants | |
| Serum 25-Hydroxy Vitamin D3 Level | Vitamin D3 (Biodal 50,000IU) | 48.2 | Standard Error 2.03 | ng/ml | |
| Serum 25-Hydroxy Vitamin D3 Level | Placebo | 11.8 | Standard Error 0.76 | ng/ml | |
| Serum Chromium Concentration | Vitamin D3 (Biodal 50,000IU) | 0.27 | Standard Error 0.01 | ppm | |
| Serum Chromium Concentration | Placebo | 0.27 | Standard Error 0.01 | ppm |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vitamin D3 (Biodal 50,000IU) | 30 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | Vitamin D3 (Biodal 50,000IU) | 29 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | Vitamin D3 (Biodal 50,000IU) | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | In-compliance , Withdral | Social circumstances | Vitamin D3 (Biodal 50,000IU) | 1 | 30 | 1 |
| other | In-compliance , Withdral | Social circumstances | Placebo | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vitamin D3 (Biodal 50,000IU) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vitamin D3 (Biodal 50,000IU) | 1 | 30 |
| Total, other adverse events | Placebo | 1 | 30 |
| Total, serious adverse events | Vitamin D3 (Biodal 50,000IU) | 0 | 30 |
| Total, serious adverse events | Placebo | 0 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33010974 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vitamin D3 (Biodal 50,000IU) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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