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Completed

NCT Number: NCT05505253

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

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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Universitas Padjadjaran

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

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

Primary outcomes

  1. Vitamin D3 levels

    Time frame: 3 months

    Vitamin D3 levels measured using lab tests

  2. Vitamin D receptor levels

    Time frame: 3 months

    Vitamin D receptor levels as assessed by ELISA

  3. Levator ani muscle strength

    Time frame: 3 months

    Levator ani muscle strength as measured using anometry

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2022
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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