Melatonin-Micronutrients for Osteopenia Treatment Study
Sleutelwoorden
Abstract
Datums
Laatst geverifieerd: | 01/31/2017 |
Eerste ingediend: | 06/02/2013 |
Geschatte inschrijving ingediend: | 06/02/2013 |
Eerst geplaatst: | 06/04/2013 |
Laatste update ingediend: | 06/11/2018 |
Laatste update geplaatst: | 06/13/2018 |
Werkelijke startdatum van het onderzoek: | 07/31/2013 |
Geschatte primaire voltooiingsdatum: | 02/08/2017 |
Geschatte voltooiingsdatum van het onderzoek: | 02/08/2017 |
Conditie of ziekte
Interventie / behandeling
Dietary Supplement: Fiber pill
Dietary Supplement: strontium/melatonin/Vitamins K2 and D3
Fase
Armgroepen
Arm | Interventie / behandeling |
---|---|
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: strontium/melatonin/Vitamins K2 and D3 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) |
Geschiktheidscriteria
Geslachten die in aanmerking komen voor studie | Female |
Accepteert gezonde vrijwilligers | Ja |
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. |
Resultaat
Primaire uitkomstmaten
1. Changes in bone mineral density from baseline to one year following treatment [One year]