Human Biomarkers for Assessing Copper Deficiency

NCT01177579 | Unknown Phase 1

• 1 other identifier: 00006969
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Bariatric surgery, copper deficiency, biomarkers

Outcome Measures

Primary Outcomes (1)

• copper co-enzymes

  expression of CCS, SOD and COX4 in blood samples

  1 year

Secondary Outcomes (1)

• blood copper concentrations

  2 months

Study Arms (3)

Aim 1; Biomarkers

NO INTERVENTION

Blood concentrations of copper coenzymes will be monitored for 1 year

Copper supplement Arm

EXPERIMENTAL

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

Dietary Supplement: Copper gluconate

Normal Controls

NO INTERVENTION

Normal subjects will be used to generate reference measures.

Interventions

Copper gluconate DIETARY_SUPPLEMENT

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

Copper supplement Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

RECRUITING

MeSH Terms

Interventions

Gluconates

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Nana Gletsu Miller, PhD

CONTACT

765-496-9462; ngletsum@purdue.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Foods and Nutrition

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 9, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)