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

NCT05505253 | Completed Phase 3 DMC

• 1 other identifier: OBGY-202206.03.
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Vitamin D3 levels

  Vitamin D3 levels measured using lab tests

  3 months

• Vitamin D receptor levels

  Vitamin D receptor levels as assessed by ELISA

  3 months

• Levator ani muscle strength

  Levator ani muscle strength as measured using anometry

  3 months

Study Arms (2)

Alfacalcidol

ACTIVE COMPARATOR

Alfacalcidol 0.5 mcg orally given for 3 months

Drug: Alfacalcidol 0.0005 MG

Control

PLACEBO COMPARATOR

Placebo given orally for 3 months

Drug: Placebo

Interventions

Alfacalcidol 0.0005 MG DRUG

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

Alfacalcidol

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Universitas Padjadjaran

Bandung, West Java, 40161, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 31039170 RESULT

• 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.

  PMID: 33935807 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• RM Sonny Sasotya, Ph.D.

  Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: November 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: until 31 December 2026
• Access Criteria: Access will be given upon written request to the authorrs

Locations

ID (1)