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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505253
• Other study ID #: OBGY-202206.03.
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
Indonesia	Universitas Padjadjaran	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

Latham CM, Brightwell CR, Keeble AR, Munson BD, Thomas NT, Zagzoog AM, Fry CS, Fry JL. Vitamin D Promotes Skeletal Muscle Regeneration and Mitochondrial Health. Front Physiol. 2021 Apr 14;12:660498. doi: 10.3389/fphys.2021.660498. eCollection 2021. Review — View Citation

Zhang L, Quan M, Cao ZB. Effect of vitamin D supplementation on upper and lower limb muscle strength and muscle power in athletes: A meta-analysis. PLoS One. 2019 Apr 30;14(4):e0215826. doi: 10.1371/journal.pone.0215826. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D3 levels	Vitamin D3 levels measured using lab tests	3 months
Primary	Vitamin D receptor levels	Vitamin D receptor levels as assessed by ELISA	3 months
Primary	Levator ani muscle strength	Levator ani muscle strength as measured using anometry	3 months