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

Sponsor
Universitas Padjadjaran (Other)
Overall Status
Completed
CT.gov ID
NCT05505253
Collaborator
(none)
48
1
2
14
3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Alfacalcidol 0.0005 MG
  • Drug: Placebo
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients
Actual Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Vitamin D3 levels [3 months]

    Vitamin D3 levels measured using lab tests

  2. Vitamin D receptor levels [3 months]

    Vitamin D receptor levels as assessed by ELISA

  3. Levator ani muscle strength [3 months]

    Levator ani muscle strength as measured using anometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitas Padjadjaran Bandung West Java Indonesia 40161

Sponsors and Collaborators

  • Universitas Padjadjaran

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitas Padjadjaran
ClinicalTrials.gov Identifier:
NCT05505253
Other Study ID Numbers:
  • OBGY-202206.03.
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Universitas Padjadjaran
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022