Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/05/2007
Date assigned
12/06/2007
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jesse Bertinato

ORCID ID

Contact details

HPFB
Nutrition Research Division
Health Canada
PL 2203C
Sir Frederick G. Banting Research Centre
251 Sir Frederick Banting Driveway
Ottawa
K1A 0L2
Canada
+1 613 957 0924
jesse_bertinato@hc-sc.gc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ZIP (Zinc Intake Project)

Study hypothesis

High intakes of zinc reduce copper status in healthy children.

Ethics approval

Approval received from:
1. Health Canada’s Research Ethics Board on the 2nd September 2005 (ref: REB-2004-0057)
2. University of Guelph Research Ethics Board on the 4th May 2005 (ref: REB# 05JA018)

Study design

Randomised, double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Decreased copper status

Intervention

Each boy (25 per group) will take two zinc tablets per day (one in the morning with breakfast and one in the evening with dinner) for 120 days that will provide a total of either 0 (placebo group), 5, 10 or 15 milligrams of supplemental zinc per day.

Subjects will be measured and weighed at the beginning (Day 0), middle (Day 60) and end (Day 120) of the study. Blood and urine samples will be collected at Day 0, 60 and 120 to assess general health of the boys and determine zinc and copper status.

The amounts of zinc and copper obtained by diet will be assessed by a three-day food record (to be completed by the caregivers of the boys at the beginning and end of the study) and food frequency questionnaire (to be completed by the caregivers of the boys at the end of the study).

Intervention type

Drug

Phase

Not Specified

Drug names

Zinc

Primary outcome measures

Effects of different levels of zinc intake on copper status will be determined by measuring the following indices of copper nutriture:
1. Expression of erythrocyte copper chaperone for Cu/Zn superoxide dismutase
2. Plasma copper concentration
3. Plasma ceruloplasmin activity
4. Erythrocyte Cu/Zn superoxide dismutase activity

Secondary outcome measures

Effects of different levels of zinc intake on:
1. Height
2. Weight
3. Complete blood counts
4. Lipid profile

Overall trial start date

01/02/2007

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy boys 7 to 8 years of age
2. Boys not taking a mineral supplement and have not taken a mineral supplement three months prior to commencing the study
3. Boys not taking sodium fluoride or aspirin
4. Boys living in Guelph, Ontario vicinity
5. Informed consent by the caregivers of the boys
6. Assent by the boys

Participant type

Patient

Age group

Child

Gender

Male

Target number of participants

100

Participant exclusion criteria

Individuals not fulfilling the above inclusion criteria.

Recruitment start date

01/02/2007

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Canada

Trial participating centre

HPFB, Nutrition Research Division
Ottawa
K1A 0L2
Canada

Sponsor information

Organisation

Health Canada (Canada)

Sponsor details

Sir Frederick G. Banting Research Centre
251 Sir Frederick Banting Driveway
Ottawa
K1A 0L2
Canada
jesse_bertinato@hc-sc.gc.ca

Sponsor type

Government

Website

http://www.hc-sc.gc.ca/

Funders

Funder type

Government

Funder name

Health Canada (Canada) - Nutrition Research Division (ref: project # 4500550)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23303874

Publication citations

  1. Results

    Bertinato J, Simpson JR, Sherrard L, Taylor J, Plouffe LJ, Van Dyke D, Geleynse M, Dam YY, Murphy P, Knee C, Vresk L, Holland N, Quach H, Mack DR, Cooper M, L'abbé MR, Hayward S, Zinc supplementation does not alter sensitive biomarkers of copper status in healthy boys., J. Nutr., 2013, 143, 3, 284-289, doi: 10.3945/jn.112.171306.

Additional files

Editorial Notes