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Assessment of dietary zinc intake and molecular biomarkers of zinc status in UK women
ISRCTN ISRCTN34559863
DOI 10.1186/ISRCTN34559863
ClinicalTrials.gov identifier
EudraCT number
Public title Assessment of dietary zinc intake and molecular biomarkers of zinc status in UK women
Scientific title Assessment of dietary zinc intake and molecular biomarkers of zinc status in UK women: a double-blinded randomised case-controlled study
Acronym N/A
Serial number at source N/A
Study hypothesis 1. Vegetarian women will have lower intakes of dietary zinc than non-vegetarian women
2. There will be no significant difference in serum zinc levels between the two groups in response to supplementation
3. The expression of zinc transports will respond to zinc supplementation
Lay summary Background and study aims
Dietary zinc is important for human growth, development and immunity. Minor zinc deficiency is common but difficult to assess. While blood plasma zinc has been successfully used to assess how people respond to zinc supplementation, it is a weak indicator for individual zinc status. In the UK, a lot of young women are not getting the enough zinc through their diet. Unlike many other minerals, the body has no stores of zinc to use when intakes are low. Research has shown that zinc-responsive genes can monitor zinc status. The aim of this study is to assess both the dietary intake of zinc and indicators in the body of zinc status in vegetarian and non-vegetarian women before and after supplementation.

Who can participate?
Women living in the UK aged between 19-45 years will be invited to participate in the study.

What does the study involve?
The study will look at two dietary groups of women: vegetarian and non-vegetarian. Within their dietary groups, women will be randomly allocated to receive either zinc or placebo (dummy). For each visit you will be asked to come in without having eaten or drunk anything apart from water. You will also be asked not to brush your teeth. A trained doctor will take two blood samples from you at the start of the study and on the 7th and 14th days of the study. In addition, you will be asked to provide a saliva sample at each visit for further analysis. You will be given a food frequency questionnaire to complete on your first visit, and will be asked to recall what you ate the day before attending the clinic at each visit.

What are the possible benefits and risks of taking part?
You will receive information of your current zinc status. When you have completed the study you will be offered a £10 Starbucks gift voucher. Once all data has been analysed, personalised feedback will be provided. There are no risks for supplementation of zinc at this level. Women in many countries have similar intakes of zinc. You may suffer from bruising from the blood sampling and embarrassment from giving a saliva sample.

Where is the study run from?
The study is run from the University of Surrey, Guildford, FHMS Clinical Investigation Unit (CIU).

When is the study starting and how long is it expected to run for?
The study started in November 2011 and recruited up until May 2012. Analysis of the information gathered from the trial is still ongoing.

Who is funding the study?
General Authority for Health Services for the Emirate of Abu Dhabi.

Who is the main contact?
Dr J. Bernadette Moore
j.b.moore@surrey.ac.uk
Ethics approval Faculty of Health and Medical Sciences (FHMS) Ethics Committee, 29 March 2011, Ref No EC/2011/02
Study design Double-blinded randomised placebo-controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Zinc deficiency
Participants - inclusion criteria 1. Healthy females
2. British residents
3. Aged between 19-45 years
Participants - exclusion criteria 1. Pregnant or breastfeeding now or in last 6 months
2. History of alcohol abuse
3. Current of recent (last 2 months) use of vitamin, mineral supplements
4. History of eating disorder
5. Consumption of meat, poultry or fish in the last year (for vegetarian group)
6. Recent traumas or surgery
Anticipated start date 01/05/2011
Anticipated end date 01/12/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet.
Target number of participants 30: 15 vegetarian (7 cases, 8 controls) and 15 non-vegetarian (7 cases, 8 controls) women
Interventions There are two dietary groups: Vegetarian and non-vegetarian. There are two treatment-sub-groups:
1. 15mg/day of zinc as zinc gluconate
2. Placebo
Total duration of intervention: 2 weeks
Route of administration: by mouth for both supplement and placebo.
Excess pills were provided and a pill count was completed after the week of supplementation in order to monitor compliance.
Primary outcome measure(s) 1. Zinc transporter (SLC30A1 and SLC39A3) transcript levels in blood and saliva.
2. Serum concentrations of zinc by blood samples
Secondary outcome measure(s) Dietary intakes of zinc, phytate and other nutrients. Zinc supplementation was measured by blood and saliva.
Sources of funding General Authority for Health Services for the Emirate of Abu Dhabi
Trial website
Publications
Contact name Dr  J. Bernadette  Moore
  Address 22 AY 03
FHMS
University of Surrey
  City/town Guildford
  Zip/Postcode GU2 7XH
  Country United Kingdom
  Tel +44 (0)1483 686405
  Email j.b.moore@surrey.ac.uk
Sponsor University of Surrey (UK)
  Address c/o Dr. J. Bernadette Moore
22 AY 03
FHMS
  City/town Guildfrod
  Zip/Postcode GU2 7XH
  Country United Kingdom
  Tel +44 (0)1483 686405
  Email j.b.moore@surrey.ac.uk
Date applied 08/08/2013
Last edited 19/09/2013
Date ISRCTN assigned 19/09/2013
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