Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/08/2013
Date assigned
19/09/2013
Last edited
19/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Bernadette Moore

ORCID ID

Contact details

22 AY 03
FHMS
University of Surrey
Guildford
GU2 7XH
United Kingdom
+44 (0)1483 686405
j.b.moore@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessment of dietary zinc intake and molecular biomarkers of zinc status in UK women: a double-blinded randomised case-controlled study

Acronym

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Zinc deficiency

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Zinc transporter (SLC30A1 and SLC39A3) transcript levels in blood and saliva.
2. Serum concentrations of zinc by blood samples

Secondary outcome measures

Dietary intakes of zinc, phytate and other nutrients. Zinc supplementation was measured by blood and saliva.

Overall trial start date

01/05/2011

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy females
2. British residents
3. Aged between 19-45 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30: 15 vegetarian (7 cases, 8 controls) and 15 non-vegetarian (7 cases, 8 controls) women

Participant 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

Recruitment start date

01/05/2011

Recruitment end date

01/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

22 AY 03
Guildford
GU2 7XH
United Kingdom

Sponsor information

Organisation

University of Surrey (UK)

Sponsor details

c/o Dr. J. Bernadette Moore
22 AY 03
FHMS
Guildfrod
GU2 7XH
United Kingdom
+44 (0)1483 686405
j.b.moore@surrey.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

General Authority for Health Services for the Emirate of Abu Dhabi

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

Publication citations

Additional files

Editorial Notes