Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

August 15, 2022 updated by: Universitas Padjadjaran
This is a study performed to evaluate the role of vitamin D supplementation on the strength of levator ani muscle in menopausal women with pelvic organ prolapse

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty eight POP women were divided into experimental and control groups in this quasi-experimental study. The experimental group was given 0.5 mcg alfacalcidol orally for three months. We measured levator ani muscle strength, serum 25-hydroxy-vitamin D3 levels, and serum Vitamin D Receptor (VDR) levels at zero months and three months preoperative. Enzyme-linked immunosorbent assay (ELISA) assessed VDR and myoblast determination protein 1 (MyoD) protein expressions in levator ani muscle surgical biopsies.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Universitas Padjadjaran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients with pelvic organ prolapse stages III and IV who underwent surgery at menopausal age
  • normal BMI
  • initial serum vitamin D levels <30 ng/mL

Exclusion Criteria:

  • comorbidities (chronic cough, conspitation)
  • vitamin D metabolism or immune system interfering diseases or drugs specific routine medications such as anticonvulsants, statin, fibrate or orlistat
  • history of vitamin D supplementation within the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alfacalcidol
Alfacalcidol 0.5 mcg orally given for 3 months
Drug: Alfacalcidol 0.0005 MG
Alfacalcidol 0.5 mcg is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured
PLACEBO_COMPARATOR: Control
Placebo given orally for 3 months
Drug: Placebo
Placebo drug is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D3 levels
Time Frame: 3 months
Vitamin D3 levels measured using lab tests
3 months
Vitamin D receptor levels
Time Frame: 3 months
Vitamin D receptor levels as assessed by ELISA
3 months
Levator ani muscle strength
Time Frame: 3 months
Levator ani muscle strength as measured using anometry
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Principal Investigator: RM Sonny Sasotya, Ph.D., Universitas Padjadjaran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ACTUAL)

October 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (ACTUAL)

August 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBGY-202206.03.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised patient data are available upon written request to the authors

IPD Sharing Time Frame

until 31 December 2026

IPD Sharing Access Criteria

Access will be given upon written request to the authorrs

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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