NCT04650880

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Dec 2026

First Submitted

Initial submission to the registry

November 19, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

3.9 years

First QC Date

November 19, 2020

Last Update Submit

May 13, 2024

Conditions

Polycystic Ovary SyndromeAnovulation

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

    Serum progesterone

    12 months

Secondary Outcomes (10)

  • Change in serum 25(OH)D level

    12 months

  • Pregnancy rate

    12 months

  • Live birth rate

    12 months

  • Change in serum anti-Mullerian hormone level

    12 months

  • Change in antral follicle count

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000 IU once every 2 weeks for 52 weeks 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.

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo tablets with same external appearance for 52 weeks 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.

Other: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

Vitamin D supplementation

Vitamin D
PlaceboOTHER

Placebo tablets with the same external appearance

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal
  • Aged 18-40 years
  • Irregular long menstrual cycles (\>35 days)
  • PCOS according to the Rotterdam criteria
  • Agree for transvaginal ultrasound

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kwong Wah Hospital

Hong Kong, Hong Kong

RECRUITING

Princess Margaret Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Ko JKY, Yung SSF, Lai SF, Wan RSF, Wong CKY, Wong K, Cheung CL, Ng EHY, Li RHW. Effect of vitamin D in addition to letrozole on the ovulation rate of women with polycystic ovary syndrome: protocol of a multicentre randomised double-blind controlled trial. BMJ Open. 2024 Apr 29;14(4):e070801. doi: 10.1136/bmjopen-2022-070801.

    PMID: 38684265DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulation

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 3, 2020

Study Start

January 26, 2021

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Time Frame
starting 6 months after publication
Access Criteria
review by investigators

Locations

HK(3)