Melatonin-Micronutrients for Osteopenia Treatment Study (MOTS)

• ClinicalTrials.gov Identifier: NCT01870115
• Recruitment Status: Completed
• First Posted: June 5, 2013
• Last Update Posted: June 14, 2018
• Sponsor: Duquesne University
• Information provided by (Responsible Party): Duquesne University

Tracking Information

• First Submitted Date: June 3, 2013
• First Posted Date: June 5, 2013
• Last Update Posted Date: June 14, 2018
• Study Start Date: August 2013
• Actual Primary Completion Date: February 9, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2013): Changes in bone mineral density from baseline to one year following treatment [ Time Frame: One year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Melatonin-Micronutrients for Osteopenia Treatment Study
• Official Title: 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: Interventional
• Study Phase: Phase 1

Study Design

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

• Osteoporosis
• Osteopenia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2017): 23
• Original Estimated Enrollment (submitted: June 3, 2013): 20
• Actual Study Completion Date: February 9, 2017
• Actual Primary Completion Date: February 9, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01870115
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Duquesne University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duquesne University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Duquesne University
• Verification Date: February 2017