Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism

NCT00325572 | Terminated Phase 1 Results DMC

• 1 other identifier: 23275
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same sex and age children who are developing typically. The hypothesis is that there is a significant difference in the copper/zinc ratio between young children who have autism and their typically developing peers. The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be statistically higher than typically developing children. Measurements of serum copper, zinc and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those children whose ratios have not fallen below 1.25, the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed evaluation of language skills, and a variety of behaviors will be evaluated prior to and after supplementation. The study will be placebo-controlled and double blind. Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study. The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism.

Conditions

Autism; Pervasive Developmental Disorder

Outcome Measures

Primary Outcomes (1)

• Copper/Zinc Ratio of Children With Autism Compared to Typically Developing Children Phase 2: Change in Copper/Zinc Ratio With Supplementation of Zinc and Vitamin C

  Phase 2 was not initiated; no data was collected.

  16 weeks

Study Arms (2)

Oral zinc and vitamin C supplementation

ACTIVE COMPARATOR

Participant will receive oral zinc and vitamin C supplementation based on the child's weight. Blood levels of zinc, copper, liver and renal function as well as blood counts will be measured. Copper to zinc ratio will be calculated at 6 and 16 weeks

Drug: oral zinc and vitamin C supplements

Oral Placebo

PLACEBO COMPARATOR

Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.

Other: oral Placebo

Interventions

oral zinc and vitamin C supplements DRUG

Each child will be provided separate suspensions containing zinc and vitamin C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation

Oral zinc and vitamin C supplementation

oral Placebo OTHER

Each child will be provided separate Placebo suspensions C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation

Oral Placebo

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 3-8 years
• Diagnosis of autism spectrum disorder
• Serum copper/zinc ratio greater than 2.0 or as determined in phase 1 of the study

You may not qualify if:

• Known chromosomal disorder or neurological disorders other than autism

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Child Development Disorders, Pervasive

Interventions

Zinc

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Limitations and Caveats

Trial was not completed and did not progress past Phase 1 of the study protocol.

Results Point of Contact

• Title: Jeanette C. Ramer MD
• Organization: Milton S. Hershey Medical Center

jramer2@hmc.psu.edu

717 531-8414

Study Officials

• Jeanette C Ramer, MD

  Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 15, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-05

Locations

US (1)