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

Phase 3

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Drug: Placebo; Drug: Alfacalcidol 0.0005 MG

• Registration Number: NCT05505253
• Lead Sponsor: Universitas Padjadjaran

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

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 Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Last Update Submitted: 2022-08-15
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo given orally for 3 months
Alfacalcidol	Alfacalcidol 0.0005 MG	Alfacalcidol 0.5 mcg orally given for 3 months

Primary Outcome Measures

Name	Time	Method
Vitamin D receptor levels	3 months	Vitamin D receptor levels as assessed by ELISA
Levator ani muscle strength	3 months	Levator ani muscle strength as measured using anometry
Vitamin D3 levels	3 months	Vitamin D3 levels measured using lab tests

Trial Locations

Locations (1)

Universitas Padjadjaran; 🇮🇩 Bandung, West Java, Indonesia