Melatonin-Micronutrients for Osteopenia Treatment Study (MOTS)

June 12, 2018 updated by: Duquesne University

Phase 1 Study of Combination Strontium, Melatonin and Nutritional Co-factors on Bone Health and Quality of Life in Postmenopausal Women With Osteopenia

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 improving subjective measures of stress, anxiety, depression and menopause-related symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15282
        • Duquesne University Center for Pharmacy Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal
  • must be osteopenic (T-score between -2.5 and -1)
  • willingness to participate in the 12-month study
  • willingness to undergo testing of bone turnover markers before and after the drug therapies
  • willingness to provide a self-assessment on quality of life throughout the program
  • willingness to take their treatments right before bed
  • willingness to not to consume alcohol with this medication

Exclusion Criteria:

  • women in whom osteopenia is a result of some other known process (e.g. hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use).
  • women on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine
  • women with severe sleep apnea, severe COPD and those with moderate or severe hepatic or renal impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Fiber pill
2 plant fiber pills taken p.o. (by mouth) nightly for one year
Dietary supplement: Fiber Pill
This fiber pill has been manufactured to mimic the pill that contains the dietary supplements melatonin (M), strontium citrate (S), vitamin D3 (D) and vitamin K2 (K) in appearance but does not contain the supplements
Active Comparator: strontium/melatonin/Vitamins K2 and D3
2 pills taken p.o. (by mouth) nightly for one year. Each pill contains strontium citrate (225 mg), melatonin (2.5 mg), Vitamin K2 (MK7) (30 mcg) and Vitamin D3 (1000 IU)
Dietary supplement: Melatonin, Strontium citrate, Vitamins D3 and K2
Each pill has been manufactured to contain the dietary supplements 2.5mg melatonin (M), 225mg strontium citrate (S), 1000IU vitamin D3 (D) and 30mcg vitamin K2 (K)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in bone mineral density from baseline to one year following treatment
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duquesne University

Investigators

  • Principal Investigator: Paula A Witt-Enderby, PhD, Duquesne University
  • Principal Investigator: Mark Swanson, ND, Private Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

February 9, 2017

Study Completion (Actual)

February 9, 2017

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Grant Protocol Number 13-59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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