TCTR20201223008尚未招募2 期
Effects of Melatonin on Bone Metabolism in Thalassemia Patients with Low Bone Mineral Density (Randomized Controlled Study)
Faculty of Medicine, Chiang Mai university0 个研究点目标入组 64 人开始时间: 2020年12月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Years 至 50 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
尚未招募
不适用
The Effect of Melatonin on Osseointegration Of immediate Loading Implant supported Mandibular OverdenturesOral Healthbone lossPACTR201307000557125faculty of oral and d16
进行中（未招募）
1 期
The effects of melatonin treatment on bone, marrow, sleep and arterial stiffness in postmenopausal womeMedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersOsteoporosisEUCTR2020-002934-34-DKAarhus University Hospital, dept. of Diabetes and Hormonal diseases40
已完成
3 期
An assessment of effects of melatonin on metabolic effects of olanzapine in patients with schizophreniaschizophrenia.Schizophrenia, schizotypal and delusional disordersF20-f29IRCT201107187049N1Guilan University of Medical ScienceS40
进行中（未招募）
不适用
Melatonin assessment on sleep and metabolism of overweight night workersObesityRBR-6pncm9niversidade de São Paulo
已完成
2 期
Effect of Melatonin on the components of metabolic syndrome in adolescent bipolarpatients taking risperidone plus lithium carbonateBipolar disorder.Bipolar affective disorderIRCT201208071556N44Tehran University of Medical Sciences40