Anovulation, Polycystic Ovary Syndrome
Conditions
Brief summary
This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.
Detailed description
The hypothesis is that vitamin D supplementation results in significant improvement in the ovulation rate of women with PCOS either spontaneously or with oral ovulation induction agent. Anovulatory women with PCOS diagnosed by the Rotterdam criteria will be recruited. Participants will be randomized to the (1) vitamin D group or (2) placebo group. Those in the vitamin D group will take vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000IU once every 2 weeks for 52 weeks, whereas those in the placebo group will take placebo tablets with the same external appearance. Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction. The primary outcome is the ovulation rate and will be compared between the 2 groups.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D supplementation
OTHERPlacebo
Placebo tablets with the same external appearance
Sponsors
Kwong Wah Hospital
Princess Margaret Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
The Queen Elizabeth Hospital
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Premenopausal * Aged 18-40 years * Irregular long menstrual cycles (\>35 days) * PCOS according to the Rotterdam criteria * Agree for transvaginal ultrasound
Exclusion criteria
* Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months * History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants * Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive * Anticipated to use the above medications in the coming one year * Known type 2 diabetes mellitus * Refusal to join the study * Abnormal blood calcium level For those on supplements, we asked them to stop their own supplements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation rate | 12 months | Serum progesterone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 12 months | Positive urine or serum hCG test |
| Live birth rate | 12 months | Delivery of a baby after 22 completed weeks of gestational age, or with birth weight of 500 grams if the gestation age is unknown, which shows evidence of life |
| Change in serum anti-Mullerian hormone level | 12 months | serum AMH level |
| Change in antral follicle count | 12 months | Antral follicle count measured by transvaginal/ transrectal ultrasound |
| Change in serum 25(OH)D level | 12 months | Serum 25(OH)D |
| Body mass index | 12 months | Height in cm, weight in kg, to calculate the body mass index (kg/m\^2) |
| Change in waist and hip circumference | 12 months | waist and hip circumference in cm |
| Rate of diabetes mellitus/ impaired glucose intolerance | 12 months | Measured by fasting and 2 hour glucose (post 75g OGTT) |
| Change in systolic and diastolic blood pressure | 12 months | Blood pressure |
| Androgen indices | 12 months | serum androgen and androstenedione levels, SHBG |
Countries
Hong Kong
Outcome results
None listed