An investigation to determine the absorption of magnesium through the skin using a magnesium cream
| ISRCTN | ISRCTN15136969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15136969 |
| Secondary identifying numbers | LMS SF UH 00057 |
- Submission date
- 14/10/2016
- Registration date
- 21/10/2016
- Last edited
- 08/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Magnesium is needed by the human body in small amounts for good health and functioning. It has been 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 years
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
Contact information
Scientific
University of Hertfordshire
College Lane
Hatfield
AL109AB
United Kingdom
 ORCID ID |
0000-0003-2079-4584 |
|---|---|
| Phone | +44 (0)1707 286495 |
| l.s.kass@herts.ac.uk |
Study information
| Study design | Single-blind single-centre parallel-designed placebo-controlled randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Absorption of transdermal magnesium cream in humans via serum and urinary analysis |
| Study hypothesis | Magnesium can be absorbed through a transdermal cream, increasing serum levels and urinary excretion. |
| Ethics approval(s) | University of Hertfordshire Health and Human Sciences Ethics Board, 14/04/2014, ref: LMS SF UH 00057 |
| 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 feelings of well being and general health. |
| Intervention type | Supplement |
| Primary outcome measure | 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 study start date | 14/04/2014 |
| Overall study end date | 28/02/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 25 |
| Participant inclusion criteria | 1. Males and females 2. Aged 18-60 years 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 exclusion criteria | 1. Younger than 18 years and older than 60 years 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
- England
- United Kingdom
Study participating centre
Hatfield
AL10 9AB
United Kingdom
Sponsor information
University/education
College Lane
Hatfield
AL109AB
England
United Kingdom
| Phone | +44 (0)170 128 4000 |
|---|---|
| ask@herts.ac.uk | |
| Website | http://www.herts.ac.uk/ |
"ROR" |
https://ror.org/0267vjk41 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/04/2017 | Yes | No | |
| Dataset | 12/04/2017 | 08/11/2023 | No | No | |
| Protocol (other) | 12/04/2017 | 08/11/2023 | No | No |
Editorial Notes
08/11/2023: Dataset and protocol added.
18/04/2017: Publication reference added.
