Condition category
Skin and Connective Tissue Diseases
Date applied
14/10/2016
Date assigned
21/10/2016
Last edited
18/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Magnesium is needed by the human body in small amounts for good health and functioning. It has found to improve blood pressure and general well-being. It is often taken as a supplement as it may be lacking in the diet. More recently magnesium has been added to body creams and oils in order to increase magnesium levels in the body and as an alternative to taking a tablet. However, it is not known whether the magnesium in the cream is absorbed into the body. The aim of this study is to determine whether magnesium in a cream can be absorbed through the skin by assessing blood and urine levels of magnesium.

Who can participate?
Healthy men and women aged 18-60

What does the study involve?
Participants are randomly allocated to one of two groups. Those in one group apply a cream containing magnesium. Those in the other group apply a cream that does not contain magnesium. The cream is applied every day for 14 days. Before the participants start to apply the cream they provide a blood sample to check their magnesium levels, along with urine samples to check the amount of magnesium in their urine. Participants also had to record the food they ate for 4 days and complete two simple questionnaires on how they felt and their general well-being. After applying the cream for 14 days, blood and urine samples are collected and tested again along with a further 4 days of food diaries and a repeat of the two simple questionnaires. Absorption of the cream could then be measured as well as any changes in their general well-being.

What are the possible benefits and risks of participating?
Participants may benefit from the positive effects of the magnesium cream (e.g., improved well-being). They also have their diet analysed. There are no risks associated with the study apart from those associated with normal blood collection.

Where is the study run from?
University of Hertfordshire (UK)

When is the study starting and how long is it expected to run for?
April 2014 to February 2015

Who is funding the study?
University of Hertfordshire (UK)

Who is the main contact?
Ms Lindsy Kass
l.s.kass@herts.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Lindsy Kass

ORCID ID

http://orcid.org/0000-0003-2079-4584

Contact details

University of Hertfordshire
College Lane
Hatfield
AL109AB
United Kingdom
+44 (0)1707 286495
l.s.kass@herts.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LMS SF UH 00057

Study information

Scientific title

Absorption of transdermal magnesium cream in humans via serum and urinary analysis

Acronym

Study hypothesis

Magnesium can be absorbed through a transdermal cream, increasing serum levels and urinary excretion.

Ethics approval

University of Hertfordshire Health and Human Sciences Ethics Board, 14/04/2014, ref: LMS SF UH 00057

Study design

Single-blind single-centre parallel-designed placebo-controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Absorption of magnesium through a transdermal cream

Intervention

The participants were randomly assigned to one of the following two treatments:
1. The magnesium cream (intervention)
2. An aqueous cream (placebo)

Thirty pieces of paper were placed into a bag, 15 stating Mg and 15 stating placebo. On recruitment of a participant onto the trial an independent colleague pulled one of the pieces of paper from the bag and the participant was assigned to that group.

Participants administered the cream for 14 days at a dose of 2 x 5ml/day (a measured spoon being provided) containing either 56mg magnesium or placebo. The cream was rubbed into the torso and legs. Food diaries were collected for 4 days at the beginning of the trial and 4 days at the end of the trial and analysed for dietary magnesium intake. A health questionnaire was administered pre and post intervention to determine feeling of well being and general health.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Serum magnesium levels, measured through venepuncture blood collection at baseline and again within the last 2 days of the intervention.
2. Urinary excretion, measured using 24h collection and analysed at baseline and again within the last 2 days of the intervention

Secondary outcome measures

1. Habitual dietary magnesium intake, assessed via 2 x 4 day food diaries, of which 4 days were collected at the beginning of the trial and a further 4 days at the end of the trial
2. General feeling of well being, assessed using a EQ-5D Health survey and short questionnaire before and after the intervention

Overall trial start date

14/04/2014

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females
2. Aged 18-60
3. In good health
4. Not taking any medication (with the exception of the contraceptive pill and asthma inhalers)
5. Not taking a magnesium supplement in any form
6. Not having a blood borne disease

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Younger than 18 and older than 60
2. Not in good health
3. Taking medication (with the exception of the contraceptive pill and asthma inhalers)
4. Taking a magnesium supplement
5. Having a blood borne disease

Recruitment start date

23/10/2014

Recruitment end date

28/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Hertfordshire
College Lane
Hatfield
AL10 9AB
United Kingdom

Sponsor information

Organisation

University of Hertfordshire

Sponsor details

College Lane
Hatfield
AL109AB
United Kingdom
+44 (0)170 128 4000
ask@herts.ac.uk

Sponsor type

University/education

Website

http://www.herts.ac.uk/

Funders

Funder type

University/education

Funder name

University of Hertfordshire

Alternative name(s)

UH

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trialists intend to publish in a peer-reviewed journal primarily with the results of the absorption of the cream and secondarily with the results of the health questionnaires.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Ms Lindsy Kass (l.s.kass@herts.ac.uk).

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28403154

Publication citations

Additional files

Editorial Notes

18/04/2017: Publication reference added.