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
Dr Seulki Lim
Functional role of vitamin D in patients with acne
The aim of this study is to determine the effect of vitamin D supplementation on acne.
Institutional Review Board of Chungnam National University Hospital, 24/07/2014, ref: CNUH 2014-07-013
Randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
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.
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
Overall trial end date
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)
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
Recruitment end date
Countries of recruitment
Trial participating centre
Chungnam University Hospital
282, Munhwa-ro Jung-gu
Ministry of Health & Welfare
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned submission to the journal PLoS One for publication.
Intention to publish date
Participant level data
Available on request
Results - basic reporting