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NCT01870115 · ClinicalTrials.gov registry record · Phase 1
Melatonin-Micronutrients for Osteopenia Treatment Study
A Phase 1 study, sponsored by Duquesne University.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01870115 is a Phase 1 study that has completed, run by Duquesne University. The registered enrollment target is 23 participants.
The verdict
NCT01870115, a Phase 1 study, has completed, sponsored by Duquesne University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The investigators' long-term goal is to employ novel methods to improve bone formation and bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs and symptoms of degenerative joint and disc disease that commonly accompany bone loss as well as improve quality of life (QOL). These conditions generally begin silently as early as the menopause transition and progress to osteopenia and osteoporosis during the post-menopausal years in aging women. The investigators also envision this will be beneficial in aging andropausal men with these conditions. The investigators postulate that melatonin in novel combination with other natural bone-protective agents may act in a "chronosynergy" manner to prevent and correct these perturbations, reducing the risk of bone fractures, and lessening the stiffness and pain associated with bone, joint and cartilage degeneration and improving quality of life (QOL). The objective here, which is the investigators' next step in pursuit of our goal, is to assess the efficacy of an alternative therapy that uses a novel combination of bone-forming agents, melatonin, strontium (citrate)/ vitamin K2 (MK7), and vitamin D3 on bone health in a postmenopausal population. Melatonin is a novel alternative to current treatment(s) because it has multiple bone-protective and sleep-promoting activities within the body, and it is relatively safe so it can be used in an aging population without untoward side effects; strontium and vitamin D3 are shown to enhance bone mineralization and improve post-menopausal osteoporosis. The project goal is to identify if this combination therapy improves bone health and QOL compared to women taking placebo. The investigators' central hypothesis is that combination therapy using melatonin, strontium, vitamin K2, and vitamin D3 will improve bone health and overall QOL in postmenopausal women not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by imp
Interventions
- DIETARY_SUPPLEMENT Fiber Pill
- DIETARY_SUPPLEMENT Melatonin, Strontium citrate, Vitamins D3 and K2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-02-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01870115
The ClinicalTrials.gov registry entry for NCT01870115 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duquesne University, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fiber Pill is the first listed.
NCT01870115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01870115 about?
NCT01870115 is a clinical study titled "Melatonin-Micronutrients for Osteopenia Treatment Study". The investigators' long-term goal is to employ novel methods to improve bone formation and bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs and symptoms of degenerative joint and disc disease that commonly accompany bone loss as well as improve quality of l...
What is the current status of trial NCT01870115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2013-08. Estimated completion is 2017-02-09.
What interventions are being tested in trial NCT01870115?
The interventions under investigation include: Fiber Pill (DIETARY_SUPPLEMENT), Melatonin, Strontium citrate, Vitamins D3 and K2 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01870115?
This trial is sponsored by Duquesne University, which has 21 total clinical trials registered on ClinicalTrials.gov.
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