Pelvic Organ ProlapsePhase 3NCT05505253
Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients
A Phase 3 study testing Alfacalcidol 0.0005 MG in people with Pelvic Organ Prolapse, run by Universitas Padjadjaran at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Alfacalcidol 0.0005 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2020to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Alfacalcidol 0.0005 MG, Placebo
- Keywords
- Alfacalcidol, MyoD expression, pelvic organ prolapse, vitamin D receptorr, levator ani muscle strength
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfacalcidol 0.0005 MGDrug
Alfacalcidol 0.5 mcg is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured
PlaceboDrug
Placebo drug is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured
| Study group | Role | What they receive |
|---|---|---|
| Alfacalcidol | Active comparator | Alfacalcidol 0.5 mcg orally given for 3 months Receives: Drug: Alfacalcidol 0.0005 MG |
| Control | Placebo comparator | Placebo given orally for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D3 levels
Vitamin D3 levels measured using lab tests
Measured: 3 months
Vitamin D receptor levels
Vitamin D receptor levels as assessed by ELISA
Measured: 3 months
Levator ani muscle strength
Levator ani muscle strength as measured using anometry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Nov 2020
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RM Sonny Sasotya, Ph.D., Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505253
- Sponsor's protocol ID
- OBGY-202206.03.
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised patient data are available upon written request to the authors
Publications
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.
PubMed 31039170Latham 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.
PubMed 33935807
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients
- ClinicalTrials.gov ID
- NCT05505253
- Acronym / sponsor ID
- OBGY-202206.03.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Alfacalcidol, MyoD expression, pelvic organ prolapse, vitamin D receptorr, levator ani muscle strength
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfacalcidol | Active comparator | Drug: Alfacalcidol 0.0005 MGAlfacalcidol 0.5 mcg orally given for 3 months |
| Control | Placebo comparator | Drug: PlaceboPlacebo given orally for 3 months |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfacalcidol 0.0005 MGAlfacalcidol 0.5 mcg is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured | Drug | Alfacalcidol |
| PlaceboPlacebo drug is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured | Drug | Control |
Primary outcome
Vitamin D3 levels
Time frame: 3 months
Vitamin D3 levels measured using lab tests
Vitamin D receptor levels
Time frame: 3 months
Vitamin D receptor levels as assessed by ELISA
Levator ani muscle strength
Time frame: 3 months
Levator ani muscle strength as measured using anometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Results publication: PubMed 31039170Zhang 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.
- Results publication: PubMed 33935807Latham 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.
- Individual participant dataSharing planned: Yes. Anonymised patient data are available upon written request to the authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RM Sonny Sasotya, Ph.D. principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfacalcidol 0.0005 MG in people with Pelvic Organ Prolapse, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D3 levels (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.