NCT03898934

Brief Summary

To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

March 30, 2019

Last Update Submit

April 30, 2022

Conditions

PCOS

Keywords

PCOSVitamin DSupplementationOvulationPregnancy

Outcome Measures

Primary Outcomes (2)

  • Ovulation rate

    Number of mature follicles obtained

    3 months

  • Pregnancy rate

    Number of patients who get pregnant

    3 months

Study Arms (2)

Vitamin D group

EXPERIMENTAL

These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study

Drug: Vitamin D

Placebo group

PLACEBO COMPARATOR

These group will receive placebo for the same periods of study group

Drug: Placebo Oral Tablet

Interventions

Vitamin DDRUG

receive 6000iu daily for 8 weeks

Vitamin D group
Placebo Oral TabletDRUG

placebo for the same period

Placebo group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS
  • Infertile
  • Vitamin D deficient

You may not qualify if:

  • Age less than 20 and more than 35
  • Non PCOS patients
  • Obese patients
  • Previous ovarian surgery
  • Previous oophrectomy of one ovary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Both patients and gynecologists were binded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The 2 groups will be treated at the same time
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 30, 2019

First Posted

April 2, 2019

Study Start

April 1, 2019

Primary Completion

March 30, 2022

Study Completion

March 31, 2022

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

The investigators will share results

Shared Documents
STUDY PROTOCOL
Time Frame
3 months

Locations

EG(1)