90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers

NCT ID: NCT01990794

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-07-31

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.

Conditions

Cobalt Biokinetics; Safety of Cobalt Dietary Supplementation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Volunteers

Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Cardno ChemRisk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Galbraith, MD

Role: PRINCIPAL_INVESTIGATOR

Cardno ChemRisk

David Galbraith, MD

Role: STUDY_DIRECTOR

Cardno ChemRisk

References

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.

Reference Type: DERIVED

PMID: 24500148 (View on PubMed)

Other Identifiers

CR103

Identifier Type: -

Identifier Source: org_study_id