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

Polycystic Ovary Syndrome Clinical Trial

Official title:

A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650880
• Other study ID #: UW20-004
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anovulation
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D supplementation

Other:
• Placebo
Placebo tablets with the same external appearance

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Princess Margaret Hospital	Hong Kong
Hong Kong	Queen Mary Hospital, University of Hong Kong	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
The University of Hong Kong	Kwong Wah Hospital, Pamela Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Hong Kong, The Queen Elizabeth Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate	Serum progesterone	12 months
Secondary	Change in serum 25(OH)D level	Serum 25(OH)D	12 months
Secondary	Pregnancy rate	Positive urine or serum hCG test	12 months
Secondary	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	12 months
Secondary	Change in serum anti-Mullerian hormone level	serum AMH level	12 months
Secondary	Change in antral follicle count	Antral follicle count measured by transvaginal/ transrectal ultrasound	12 months
Secondary	Androgen indices	serum androgen and androstenedione levels, SHBG	12 months
Secondary	Body mass index	Height in cm, weight in kg, to calculate the body mass index (kg/m^2)	12 months
Secondary	Change in waist and hip circumference	waist and hip circumference in cm	12 months
Secondary	Rate of diabetes mellitus/ impaired glucose intolerance	Measured by fasting and 2 hour glucose (post 75g OGTT)	12 months
Secondary	Change in systolic and diastolic blood pressure	Blood pressure	12 months