N/A
N=13
90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers
Cobalt Biokinetics · Safety of Cobalt Dietary Supplementation
Bottom Line
View on ClinicalTrials.gov: NCT01990794 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Cobalt Whole Blood Concentrations — 14.6; 7.4; 33.9; 8.5 µg Co/L
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardno ChemRisk
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cobalt Whole Blood Concentrations |
14.6; 7.4; 33.9; 8.5; 29.9; 13.8 | — |
| PRIMARY Cobalt Serum Concentrations |
23.3; 11.0; 42.3; 11.8; 42.5; 20.4 | — |
| SECONDARY Albumin Bound Cobalt Fraction in Serum |
94.5; 95.2; 96.5; 93.2; 96.7; 95.6 | — |
| SECONDARY Effects on the Immune System |
1.79; 2.34; 1.05; 1.44; 1.01; 1.43 | — |
| SECONDARY Hemoglobin Levels After 1, 2 and 3 Months of Dosing |
13.5; 14.9; 13.3; 14.8; 13.2; 15.1 | — |
| SECONDARY Changes in Audiological Function |
10.0; 8.0; 9.0; 8.0; 7.5; 6.0 | — |
| SECONDARY Changes in Cardiac Function |
4.77; 4.75; 4.65; 3.15; 2.97; 2.95 | — |
| SECONDARY Changes in Visual Function |
1.29; 1.35; 1.38; 1.39; 1.31; 1.36 | — |
| SECONDARY Changes in Neurological Function (Peroneal Motor Amplitude) |
5.1; 5.5; 5.6 | — |
| SECONDARY White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation |
6.46; 6.79; 6.44; 6.42; 6.36; 6.94 | — |
| SECONDARY Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing |
4.42; 4.71; 4.28; 4.70; 4.3; 4.81 | — |
| SECONDARY Hematocrit Levels After 1, 2 and 3 Months of Dosing |
41.5; 45.1; 40.9; 45.0; 41.0; 46.3 | — |
| SECONDARY Protein Levels After 1, 2 and 3 Months of Dosing |
7.11; 7.26; 7.00; 7.24; 7.08; 7.16 | — |
| SECONDARY Albumin Levels After 1, 2 and 3 Months of Dosing |
4.39; 4.63; 4.32; 4.60; 4.34; 4.56 | — |
| SECONDARY Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing |
1.73; 2.35; 1.53; 3.35; 1.65; 3.11 | — |
| SECONDARY T4 Levels After 1, 2 and 3 Months of Dosing |
1.10; 1.15; 1.16; 1.16; 1.12; 1.16 | — |
| SECONDARY Total Iron Levels After 1, 2 and 3 Months of Dosing |
88.4; 122; 77.4; 119; 84.6; 105 | — |
| SECONDARY Ferritin Levels After 1, 2 and 3 Months of Dosing |
51.3; 136; 32.0; 95.2; 27.4; 86.6 | — |
| SECONDARY Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing |
0.61; 1.58; 0.80; 0.97; 0.59; 0.92 | — |
| SECONDARY Creatinine Levels After 1, 2 and 3 Months of Dosing |
0.79; 1.05; 0.78; 1.01; 0.77; 1.04 | — |
| SECONDARY Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing |
14.8; 30.6; 13.6; 26.2; 14.8; 32.0 | — |
| SECONDARY Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing |
18.8; 22.9; 17.6; 21.0; 20.2; 22.4 | — |
| SECONDARY HDL Cholesterol Levels After 3 Months of Cobalt Supplementation |
85.2; 50.2; 78.4; 50.6 | — |
| SECONDARY Total Cholesterol Levels After 3 Months of Cobalt Supplementation |
209; 179; 220; 188 | — |
| SECONDARY Triglyceride Levels After 3 Months of Cobalt Supplementation |
105; 113; 95.6; 122 | — |
| SECONDARY Glucose Levels After 1, 2 and 3 Months of Dosing |
88.2; 89.9; 82.2; 83.4; 86.4; 81.2 | — |
| SECONDARY Cobalt Urine Concentrations |
186; 119; 226; 46; 193; 70 | — |
| SECONDARY Cobalt Urine Concentrations After Cessation of Cobalt Supplementation |
38; 14; 19; 7; 6; 2 | — |
| SECONDARY Changes in Cardiac Function (LVEF) |
65.9; 66.8; 65.0 | — |
| SECONDARY Changes in Cardiac Function (LA Volume Index) |
23.3; 24.2; 24.0 | — |
| SECONDARY Changes in Visual Function (Average RNFL Thickness) |
97.10; 97.00; 97.00; 96.30; 96.50; 96.50 | — |
| SECONDARY Changes in Visual Function (Average C:D Ratio) |
0.43; 0.44; 0.41; 0.42; 0.40; 0.40 | — |
| SECONDARY Changes in Visual Function (Cup Volume) |
0.09; 0.08; 0.08; 0.07; 0.08; 0.07 | — |
| SECONDARY Changes in Visual Function (VFI) |
99.40; 99.30; 99.30; 99.50; 99.60; 99.70 | — |
| SECONDARY Changes in Visual Function (Mean Deviation and PSD) |
-0.22; -0.25; 0.29; 0.02; 0.26; -0.09 | — |
| SECONDARY Changes in Neurological Function (Sural Sensory Amplitude) |
24.2; 23.4; 20.7; 28.3 | — |
| SECONDARY Changes in Neurological Function (Velocity) |
42.4; 39.9; 36.4; 43.3; 58.7; 64.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01990794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.