A 90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Cobalt Whole Blood Concentrations
研究概览
简要总结
The purpose of this study is to investigate steady-state cobalt levels following dietary supplementation for 90 days with 1 mg cobalt/day (as cobalt chloride in solution) in healthy adult volunteers.
详细描述
Over the counter cobalt (Co) dietary supplements are available for sale in the United States, but little is known regarding their clinical effects and biokinetic distribution and body burden with long-term use. This study assessed blood kinetics, steady-state levels, biochemical responses, and clinical effects in five adult males and five adult females who voluntarily ingested approximately 1.0 mg Co/day of a commercially available Co supplement over a three month period. Volunteers were instructed to take the Co-dietary supplement in the morning according to the manufacturer's label. Blood samples were collected and analyzed for a number of biochemical parameters before, during, and after dosing. Hearing, vision, cardiac, and neurological functions were also assessed in volunteers before, during, and after dosing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject ≥ 18 years old.
- •Subject able to understand and willing to sign a written informed consent form for the study.
排除标准
- •Subject is unwilling to discontinue current multivitamins or other types of dietary supplements while on study
- •Subject has a documented history of an allergy to cobalt
- •Subject has a documented history of severe cardiac problems (e.g., congestive heart failure, myocardial ischemia within past 12 months, cardiomyopathy)
- •Subject has a documented history of thyroid, kidney, or liver disease
- •Subject has insulin-dependent diabetes
- •Subject has a concurrent illness or personal stressor which in the opinion of the investigator may interfere with the subject's ability to perform the study's requirements.
- •Subject has a total joint replacement (e.g., knee, hip, shoulder)
- •Subject is pregnant or breastfeeding
- •Subject is unwilling to follow protocol requirements
- •Subject weight is less than 45 kg
结局指标
主要结局
Cobalt Whole Blood Concentrations
时间窗: Before, during and after cobalt supplementation
The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.
Cobalt Serum Concentrations
时间窗: Before, during and after cobalt supplementation
The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.
次要结局
- Changes in Audiological Function(Baseline, at the study midpoint, and at the study completion)
- Effects on the Immune System(0 weeks and three months)
- Albumin Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Albumin Bound Cobalt Fraction in Serum(Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers)
- Changes in Visual Function(Baseline, at the study midpoint, and at the study completion)
- Hemoglobin Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Changes in Neurological Function (Peroneal Motor Amplitude)(Baseline, at the study midpoint, and at the study completion)
- White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Changes in Cardiac Function(Baseline, at the study midpoint, and at the study completion)
- Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Hematocrit Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Protein Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Ferritin Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Creatinine Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- T4 Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Total Iron Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Glucose Levels After 1, 2 and 3 Months of Dosing(Study volunteers were assessed before, during and after cobalt supplementation (2 wk post))
- Cobalt Urine Concentrations(During cobalt supplementation)
- Changes in Cardiac Function (LA Volume Index)(Baseline, at the study midpoint, and at the study completion)
- HDL Cholesterol Levels After 3 Months of Cobalt Supplementation(Study volunteers were assessed before and at the end of cobalt supplementation)
- Total Cholesterol Levels After 3 Months of Cobalt Supplementation(Study volunteers were assessed before and at the end of cobalt supplementation)
- Triglyceride Levels After 3 Months of Cobalt Supplementation(Study volunteers were assessed before and at the end of cobalt supplementation)
- Changes in Visual Function (Average RNFL Thickness)(Baseline, at the study midpoint, and at the study completion)
- Changes in Visual Function (Average C:D Ratio)(Baseline, at the study midpoint, and at the study completion)
- Cobalt Urine Concentrations After Cessation of Cobalt Supplementation(After cobalt supplementation)
- Changes in Visual Function (Mean Deviation and PSD)(Baseline, at the study midpoint, and at the study completion)
- Changes in Neurological Function (Sural Sensory Amplitude)(Baseline, at the study midpoint, and at the study completion)
- Changes in Cardiac Function (LVEF)(Baseline, at the study midpoint, and at the study completion)
- Changes in Visual Function (Cup Volume)(Baseline, at the study midpoint, and at the study completion)
- Changes in Visual Function (VFI)(Baseline, at the study midpoint, and at the study completion)
- Changes in Neurological Function (Velocity)(Baseline, at the study midpoint, and at the study completion)