Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/08/2013
Date assigned
19/09/2013
Last edited
13/12/2017
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 19-45

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

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

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

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

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, 29/03/2011, ref: 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 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. 15 mg/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

Supplement

Phase

Drug names

Primary outcome measure

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 (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Healthy volunteer

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

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Surrey
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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/12/2017: No publications found, verifying study status with principal investigator.