Condition category
Skin and Connective Tissue Diseases
Date applied
06/10/2015
Date assigned
15/10/2015
Last edited
15/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vitamin D is essential for good health, because it helps our bodies to absorb calcium from the diet. There is a lot of evidence that vitamin D can help protect against many diseases, such as heart disease, bone diseases and cancer. Although vitamins generally come from the diet, the majority of people actually get most of their vitamin D from sunlight. When the sun shines on our skin, a reaction in the body is triggered, producing an active form of vitamin D (known as vitamin D3). Vitamin D plays an important role in the immune system and low levels in the body have been linked to various skin diseases. Acne is a very common skin condition that causes spots to develop on the skin, particularly on the face, back and chest. It is caused by when small oil glands (sebaceous glands) produce too much oil (sebum) which blocks pores and causes inflammation. Recent studies have suggested that vitamin D deficiency may be linked to the development of acne, however the reason why is still unclear. In this study, the levels of vitamin D will be compared in people with and without acne to see if there is a link between acne and vitamin D deficiency. The study will then find out whether taking a vitamin D3 supplement (cholecalciferol) is an effective way to treat acne.

Who can participate?
Adults between 20 and 35 years with acne, and healthy adults of the same age.

What does the study involve?
In the first part of the study, the patients with acne and the healthy participants have a blood test so that their vitamin D levels can be measured. In the second part of the study, the acne patients are randomly allocated to one of two groups. Those in the first group take the vitamin D supplement cholecalciferol by mouth every day for two months. Those in the second group take an identical looking placebo (inactive medication) every day for two months. Participants in both groups are examined by experts at the start of the study and then at 2, 4 and 8 weeks in order to judge the severity of their acne.

What are the possible benefits and risks of participating?
A benefit of taking part in the study is that all participants are able to find out whether they have a vitamin D deficiency, and patients involved in the second part of the study have the change of receiving vitamin D supplements. There are no major risks of participating, although there is a risk of pain or bruising during blood tests.

Where is the study run from?
Chungnam University Hospital (South Korea)

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

Who is funding the study?
Ministry of Health & Welfare (South Korea)

Who is the main contact?
Dr Seulki Lim

Trial website

Contact information

Type

Public

Primary contact

Dr Seulki Lim

ORCID ID

http://orcid.org/0000-0002-9907-0628

Contact details

282 Munhwa-ro
Jung-gu
Daejeon
35015
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Functional role of vitamin D in patients with acne

Acronym

Study hypothesis

The aim of this study is to determine the effect of vitamin D supplementation on acne.

Ethics approval

Institutional Review Board of Chungnam National University Hospital, 24/07/2014, ref: CNUH 2014-07-013

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acne

Intervention

Acne patients and healthy controls have a blood test so that their serum 25-hydroxy vitamin D (25(OH)D) concentrations can be measured measured.
The acne patients were randomly assigned to either a 2 month oral administration of cholecalciferol (one drop of 1000 IU/day, n=20) or an identical-appearing placebo drop (n=19). Any other topical or systemic acne treatments, except for standard washing and moisturizing, were not allowed.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Serum vitamin D level in patients with acne and healthy controls is measured using blood analysis of 25-hydroxy vitamin D (25(OH)D) concentration at baseline.

Secondary outcome measures

1. The severity of acne was assessed using digital photographs and the global acne grading system (GAGS) score at baseline, 2, 4 and 8 weeks
2. Counts of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules) were made at each visit, and dermatological assessments were performed blind by three independent dermatologists

Overall trial start date

01/11/2014

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged between 20 and 35 years with acne
2. Adults aged between 20 and 35 years without acne (healthy controls)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

This study includes 80 patients with acne and 80 healthy controls.

Participant exclusion criteria

1. Receiving therapeutic interventions such as acne treatment, systemic corticosteroids, vitamin D supplements
2. Subjects with concomitant inflammatory diseases

Recruitment start date

01/11/2014

Recruitment end date

28/02/2015

Locations

Countries of recruitment

Korea, South

Trial participating centre

Chungnam University Hospital
282, Munhwa-ro Jung-gu
Daejeon
35015
Korea, South

Sponsor information

Organisation

Chungnam National University Hospital

Sponsor details

282 Munhwa-ro
Jung-gu
Daejeon
35015
Korea
South

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Ministry of Health & Welfare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submission to the journal PLoS One for publication.

Intention to publish date

31/03/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes