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Melatonin-Micronutrients for Osteopenia Treatment Study (MOTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01870115
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : June 14, 2018
Information provided by (Responsible Party):
Duquesne University

Tracking Information
First Submitted Date  ICMJE June 3, 2013
First Posted Date  ICMJE June 5, 2013
Last Update Posted Date June 14, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
Changes in bone mineral density from baseline to one year following treatment [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Melatonin-Micronutrients for Osteopenia Treatment Study
Official Title  ICMJE Phase 1 Study of Combination Strontium, Melatonin and Nutritional Co-factors on Bone Health and Quality of Life in Postmenopausal Women With Osteopenia
Brief 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 improving subjective measures of stress, anxiety, depression and menopause-related symptoms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Melatonin (5mg), strontium (citrate; 450mg) vitamin D3 (2000IU)and vitamin K2 (MK7; 60mcg)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Osteopenia
Intervention  ICMJE
  • 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
  • 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)
Study Arms  ICMJE
  • Placebo Comparator: Fiber pill
    2 plant fiber pills taken p.o. (by mouth) nightly for one year
    Intervention: Dietary Supplement: Fiber Pill
  • 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)
    Intervention: Dietary Supplement: Melatonin, Strontium citrate, Vitamins D3 and K2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2013)
Actual Study Completion Date  ICMJE February 9, 2017
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01870115
Other Study ID Numbers  ICMJE Grant Protocol Number 13-59
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Duquesne University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duquesne University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paula A Witt-Enderby, PhD Duquesne University
Principal Investigator: Mark Swanson, ND Private Practice
PRS Account Duquesne University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP