Re-evaluation of the upper level of intake for zinc using novel molecular biomarkers of copper status
| ISRCTN | ISRCTN77377400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77377400 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/05/2007
- Registration date
- 12/06/2007
- Last edited
- 08/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Jesse Bertinato
Scientific
Scientific
HPFB, Nutrition Research Division
Health Canada, PL 2203C
Sir Frederick G. Banting Research Centre
251 Sir Frederick Banting Driveway
Ottawa
K1A 0L2
Canada
| Phone | +1 613 957 0924 |
|---|---|
| jesse_bertinato@hc-sc.gc.ca |
Study information
| Study design | Randomised, double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ZIP (Zinc Intake Project) |
| Study hypothesis | High intakes of zinc reduce copper status in healthy children. |
| Ethics approval(s) | Approval received from: 1. Health Canadas 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) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Zinc |
| Primary outcome measure | 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 study start date | 01/02/2007 |
| Overall study end date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 8 Years |
| Sex | Male |
| Target number of participants | 100 |
| 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 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
Study participating centre
HPFB, Nutrition Research Division
Ottawa
K1A 0L2
Canada
K1A 0L2
Canada
Sponsor information
Health Canada (Canada)
Government
Government
Sir Frederick G. Banting Research Centre
251 Sir Frederick Banting Driveway
Ottawa
K1A 0L2
Canada
| jesse_bertinato@hc-sc.gc.ca | |
| Website | http://www.hc-sc.gc.ca/ |
"ROR" |
https://ror.org/05p8nb362 |
Funders
Funder type
Government
Health Canada (Canada) - Nutrition Research Division (ref: project # 4500550)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No |
