Clinical trial NCT01990794: 90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers
Official title: A 90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cobalt Biokinetics
Safety of Cobalt Dietary Supplementation
Keywords: Cobalt
Dietary Supplements
Hematological
Thyroid
Lead sponsor: Cardno ChemRisk
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2013-11-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers from work site and off work site

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject ≥ 18 years old.
* Subject able to understand and willing to sign a written informed consent form for the study.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cobalt Whole Blood Concentrations
timeFrame: Before, during and after cobalt supplementation
measure: Cobalt Serum Concentrations
timeFrame: Before, during and after cobalt supplementation
Secondary outcomes:
measure: Albumin Bound Cobalt Fraction in Serum
timeFrame: Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers
measure: Effects on the Immune System
timeFrame: 0 weeks and three months
measure: Hemoglobin Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Changes in Audiological Function
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Cardiac Function
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Visual Function
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Neurological Function (Peroneal Motor Amplitude)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Hematocrit Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Protein Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Albumin Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: T4 Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Total Iron Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Ferritin Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Creatinine Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: HDL Cholesterol Levels After 3 Months of Cobalt Supplementation
timeFrame: Study volunteers were assessed before and at the end of cobalt supplementation
measure: Total Cholesterol Levels After 3 Months of Cobalt Supplementation
timeFrame: Study volunteers were assessed before and at the end of cobalt supplementation
measure: Triglyceride Levels After 3 Months of Cobalt Supplementation
timeFrame: Study volunteers were assessed before and at the end of cobalt supplementation
measure: Glucose Levels After 1, 2 and 3 Months of Dosing
timeFrame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
measure: Cobalt Urine Concentrations
timeFrame: During cobalt supplementation
measure: Cobalt Urine Concentrations After Cessation of Cobalt Supplementation
timeFrame: After cobalt supplementation
measure: Changes in Cardiac Function (LVEF)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Cardiac Function (LA Volume Index)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Visual Function (Average RNFL Thickness)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Visual Function (Average C:D Ratio)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Visual Function (Cup Volume)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Visual Function (VFI)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Visual Function (Mean Deviation and PSD)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Neurological Function (Sural Sensory Amplitude)
timeFrame: Baseline, at the study midpoint, and at the study completion
measure: Changes in Neurological Function (Velocity)
timeFrame: Baseline, at the study midpoint, and at the study completion
Other outcomes:
Locations:
Study officials:
affiliation: Cardno ChemRisk
name: David Galbraith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardno ChemRisk
name: David Galbraith, MD
role: STUDY_DIRECTOR
References:
citation: Tvermoes BE, Unice KM, Paustenbach DJ, Finley BL, Otani JM, Galbraith DA. Effects and blood concentrations of cobalt after ingestion of 1 mg/d by human volunteers for 90 d. Am J Clin Nutr. 2014 Mar;99(3):632-46. doi: 10.3945/ajcn.113.071449. Epub 2014 Feb 5.