Polycystic Ovary Syndrome, Vitamin D Deficiency
Conditions
Keywords
Polycystic Ovary Syndrome, Vitamin D, Anti Mullerian Hormone, Soluble receptor for Advanced Glycation End Products
Brief summary
The purpose of this study is to investigate the mechanism that explain the beneficial clinical effect of vitamin D treatment in women with PCOS.
Detailed description
Seventy-nine women with (n=22) or without (control; n=57) PCOS who were diagnosed with vitamin D deficiency were enrolled. Sixty-three women were treated with oral vit D3 for 8 weeks (16 with PCOS and 47 controls) and 16 women were not treated (6 with PCOS and 10 controls). Serum 25 hydroxy-vitamin D (25 OH-D), sRAGE, and AMH concentrations were measured at baseline and after vit D3 supplementation in the treated group, and 8 weeks apart in the non-treated group. Paired t-test, Wilcoxon signed-rank test, and Pearson correlation were used as appropriate. Main outcome measure: Changes in AMH concentrations following vit D3 replacement.
Interventions
DRUGVitamin D3
Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
Sponsors
Maimonides Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
* Vitamin D deficient premenopausal women
Exclusion criteria
* Pregnant women * Women during their postpartum period * Breastfeeding women * Women taking any kind of exogenous hormones * Women receiving any form of oral vitamin D replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AMH Levels in Women With PCOS | 8 weeks after completing vitamin D treatment | AMH measured by serum analysis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Treatment Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
Vitamin D3: Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment. | 63 |
| Non Treated Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment. | 16 |
| Total | 79 |
Baseline characteristics
| Characteristic | Vitamin D Treatment | Non Treated | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 16 Participants | 79 Participants |
| Region of Enrollment United States | 63 participants | 16 participants | 79 participants |
| Sex: Female, Male Female | 63 Participants | 16 Participants | 79 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 63 | 0 / 16 |
| serious Total, serious adverse events | 0 / 63 | 0 / 16 |
Outcome results
Primary
AMH Levels in Women With PCOS
AMH measured by serum analysis
Time frame: 8 weeks after completing vitamin D treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Treatment | AMH Levels in Women With PCOS | 1.4 ng/mL | Standard Deviation 0.55 |
| Non Treated | AMH Levels in Women With PCOS | 0 ng/mL | Standard Deviation 0.5 |