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

Universitas Padjadjaran

Status and phase

Completed

Phase 3

Conditions

Pelvic Organ Prolapse

Treatments

Drug: Placebo

Drug: Alfacalcidol 0.0005 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT05505253

OBGY-202206.03.

Details and patient eligibility

About

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

Full 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.

Enrollment

48 patients

Sex

Female

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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