Human Biomarkers for Assessing Copper Deficiency

NCT ID: NCT01177579

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2018-12-31

Brief Summary

Copper is an essential nutrient for humans and is cofactor in enzymes that participate in critical body functions. Insufficient copper can lead to hematological and neurological abnormalities that may be irreversible if left untreated. Copper deficiency is believed to be rare in the U.S. population because typical dietary intake is usually sufficient to meet requirements. More recent evidence suggests that specific populations may be susceptible to copper deficiency in cases where copper absorption in the gut is impaired following gastric surgery or in individuals with high intakes of zinc. Preliminary studies by us and others have identified significant levels of moderate and severe symptomatic copper deficiency in patients who have undergone weight loss (bariatric) gastric bypass surgery. Copper deficiency in humans is difficult to recognize and treat because current diagnostic tools rely on measures of plasma concentrations of copper and ceruloplasmin, which are neither sensitive nor specific for copper deficiency, and early warning blood markers (biomarkers) have not been identified. Recent developments indicate that copper chaperone molecules and cuproenzymes such as cytochrome C oxidase and superoxide dismutase may be more sensitive to changes in copper status, but there has been very little work done in humans. The studies outlined here are aimed at assessing copper status using these biomarkers in gastric bypass surgery patients who are at risk for symptomatic copper deficiency. In addition, patients identified to be deficient will be supplemented with copper and this treatment will be evaluated using biomarker concentrations. The findings of these studies should provide insight into the effectiveness of novel biomarkers to identify those at risk and to guide appropriate treatment to prevent serious and permanent morbidity due to copper deficiency.

Conditions

Copper Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Aim 1; Biomarkers

Blood concentrations of copper coenzymes will be monitored for 1 year

Group Type: NO_INTERVENTION

No interventions assigned to this group

Copper supplement Arm

4 mg or 8 mg copper will be compared in a randomized controlled study

Group Type: EXPERIMENTAL

Copper gluconate

Intervention Type: DIETARY_SUPPLEMENT

4 or 8 mg copper gluconate/day will be assessed for efficacy of copper repletion

Normal Controls

Normal subjects will be used to generate reference measures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Copper gluconate

4 or 8 mg copper gluconate/day will be assessed for efficacy of copper repletion

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Exclusion Criteria

NW Control Arm For the normal-weight control arm (NW Control), subjects who have not had bariatric surgery and are of normal weight will be recruited.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Nana Gletsu-Miller

Assistant Professor, Foods and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Purdue University

West Lafayette, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nana Gletsu Miller, PhD

Role: CONTACT

ngletsum@purdue.edu

765-496-9462

Facility Contacts

Nana Gletsu Miller, PhD

Role: primary

ngletsum@purdue.edu

765-496-9462

Other Identifiers

00006969

Identifier Type: -

Identifier Source: org_study_id