Low bone mineral density (BMD Z-
Conditions
Interventions
Natrol Melatonin Time-
Release 10 mg/tab 2 tablets orally once a day at bedtime,Placebo 2 tablets orally once a day at bedtime
Experimental Dietary Supplement,Placebo Comparator No treatment
Melatonin time-
release 20 mg,Placebo
Sponsors
Faculty of Medicine, Chiang Mai university
Faculty of Medicine,
Chiang Mai university
Eligibility
Sex/Gender
All
Age
19 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male or premenopausal female with age 19-50 years 2. Thalassemia disease, either TDT or NTDT, confirmed by hemoglobin typing (High Performance Liquid Chromatography method) or PCR for thalassemia gene result 3. Iron overload defined as serum ferritin more than 1,000 ng/ml in TDT or 800 ng/ml in NTDT 4. The axial BMD is less than -2 standard deviation of the reference value for that age (Z-score < -2.0) 5. Physically fit defined as ECOG performance status 0-1
Exclusion criteria
Exclusion criteria: 1. Currently use or history of any bone modifying agent use within 1 year before enrollment: bisphosphonates, RANKL inhibitor, sclerostin inhibitor, SERMs, strontium ranelate (not include calcium and vitamin D) 2. Pregnancy or breastfeeding 3. History of allergy or severe adverse event from melatonin 4. Cannot evaluate BMD by DXA at L-spine and hips
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference of BMD at L-spine 12 months BMD | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean difference of BMD at proximal femur 12 months BMD,Serum bone turnover marker (CTX, P1NP) differences between groups 6, 12 months Blood,Pain score differences between groups 6, 12 months Questionnaire (Numeric rating scale),changes of serum NTBI, hepcidin 6, 12 months Blood,changes of plasma F2-isoprostanes, melatonin, calcitonin, FGF21 level 6, 12 months Blood,Adverse events 3, 6, 9, 12 months Questionnaire | — |
Countries
Thailand
Contacts
Public ContactPokpong Piriyakhuntorn
Outcome results
None listed