NCT05505253

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Universitas Padjadjaran · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
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
DRUG	Placebo	Placebo drug is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2022-08-17
• Last updated: 2022-08-17

Locations

1 site across 1 country: Indonesia