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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Drug: Alfacalcidol 0.0005 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alfacalcidol<br>Alfacalcidol 0.5 mcg orally given for 3 months | Drug: Alfacalcidol 0.0005 MG<br>* Alfacalcidol 0.5 mcg is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured<br>|
| Placebo Comparator: Control<br>Placebo given orally for 3 months | Drug: Placebo<br>* Placebo drug is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alfacalcidol, MyoD expression, pelvic organ prolapse, vitamin D receptorr, levator ani muscle strength