The effect of vitamin D supplementation in patients with systemic lupus erythematosus
| ISRCTN | ISRCTN59058825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59058825 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 54/2016 |
| Sponsor | University of Malta |
| Funder | Università ta' Malta |
- Submission date
- 28/02/2021
- Registration date
- 12/04/2021
- Last edited
- 17/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Systemic lupus erythematosus, the most common form of lupus, is a chronic autoimmune disease that can cause severe fatigue and joint pain.
Vitamin D deficiency is common in SLE patients due to sun avoidance. The aim of this study is to analyse the effect of vitamin D supplementation on disease activity and fatigue in SLE patients who are vitamin D deficient or insufficient.
Who can participate?
SLE patients who fulfil the SLICC classification criteria for SLE, are over the age of 18 and have been diagnosed with vitamin D deficiency and insufficiency may participate.
What does the study involve?
The study involves an interview, filling in questionnaires and blood sampling at baseline and after 6 and 12 months of vitamin D supplementation.
What are the possible benefits and risks of participating?
The benefits of participating include being provided with free vitamin D supplementation for 1 year. The risks are very minimal and include potential side effects from vitamin D supplementation.
Where is the study run from?
The study is run from Mater Dei Hospital (Malta)
When is the study starting and how long is it expected to run for?
August 2016 to August 2018
Who is funding the study?
The Faculty of Medicine and Surgery, University of Malta provided funding for this research. Quest NutraPharma sponsored the vitamin D3 supplementation but did not have any input with regards to setting up the protocol or conducting this research.
Who is the main contact?
Rosalie Magro, rosaliemagro@gmail.com
Contact information
Scientific
Department of Medicine
Mater Dei Hospital
Msida
MSD2090
Malta
 ORCID ID |
0000-0001-8486-8410 |
|---|---|
| Phone | +35679491959 |
| rosaliemagro@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre interventional open-label study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Vitamin D supplementation in systemic lupus erythematosus: relationship to disease activity, fatigue and the interferon signature gene expression |
| Study objectives | Vitamin D supplementation in SLE results in improved disease activity, particularly when vitamin D is deficient. |
| Ethics approval(s) | Approved 20/10/2016, University Research Ethics Committee, Malta Medical School, University of Malta (Msida, Malta; +356 23401214; research-ethics.committee@um.edu.mt), ref: 54/2016 |
| Health condition(s) or problem(s) studied | Treatment of vitamin D deficiency/insufficiency in patients with systemic lupus erythematosus |
| Intervention | SLE patients with vitamin D deficiency or insufficiency are supplemented with vitamin D3 8000IU daily for 8 weeks if they are vitamin D deficient, or 8000IU daily for 4 weeks if they are insufficient. This is followed by 2000IU daily maintenance. They are assessed at baseline, after 6 and 12 months by means of an interview, filling in questionnaires and blood tests. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Systemic lupus erythematosus disease activity measured using SLEDAI-2K at baseline, 6 months and 12 months |
| Key secondary outcome measure(s) |
1. Fatigue measured using Fatigue Severity Scale at baseline, 6 and 12 months |
| Completion date | 20/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Fulfills the SLICC classification criteria for SLE 2. Age ≥18 years 3. The presence of vitamin D deficiency/insufficiency |
| Key exclusion criteria | Patients with stage 4 and 5 chronic kidney disease |
| Date of first enrolment | 03/11/2016 |
| Date of final enrolment | 20/07/2017 |
Locations
Countries of recruitment
- Malta
Study participating centre
Msida
MSD2090
Malta
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/12/2021 | 17/08/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/08/2022: Publication reference added.
02/03/2021: Trial’s existence confirmed by University of Malta
