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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05505253

Enrollment

Registered

2022-08-17

Start date

2020-11-01

Completion date

2021-12-31

Last updated

2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Alfacalcidol, MyoD expression, pelvic organ prolapse, vitamin D receptorr, levator ani muscle strength

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.

Interventions

DRUGAlfacalcidol 0.0005 MG

Alfacalcidol 0.5 mcg is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured

DRUGPlacebo

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Vitamin D3 levels	3 months	Vitamin D3 levels measured using lab tests
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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026