Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Premenopausal

Aged 18-40 years

Irregular long menstrual cycles (>35 days)

PCOS according to the Rotterdam criteria

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D

    Dietary supplement

    Vitamin D supplementation

  • Placebo

    Other intervention

    Placebo tablets with the same external appearance

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Vitamin DActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ovulation rate

Serum progesterone

Time frame
12 months

Secondary outcomes

1

Change in serum 25(OH)D level

Serum 25(OH)D

Time frame
12 months
2

Pregnancy rate

Positive urine or serum hCG test

Time frame
12 months
3

Live birth rate

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

Time frame
12 months
4

Change in serum anti-Mullerian hormone level

serum AMH level

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Kwong Wah Hospital

Collaborator

Princess Margaret Hospital, Hong Kong

Collaborator

Pamela Youde Nethersole Eastern Hospital

Collaborator

The Queen Elizabeth Hospital

Collaborator