The ability of body lotion containing provitamin D3 to reduce itching in patients with chronic kidney disease undergoing routine hemodialysis
| ISRCTN | ISRCTN27942151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27942151 |
- Submission date
- 27/12/2022
- Registration date
- 06/01/2023
- Last edited
- 16/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Itching (pruritus) is often experienced by patients with chronic kidney disease (CKD) undergoing hemodialysis (HD), resulting in poor sleep quality which can affect the patient's quality of life. Several studies have shown dry skin, decreased vitamin D levels, and increased inflammatory markers (one of which is interleukin-31/IL-31) in CKD patients undergoing HD with itching complaints. Several other studies have shown that the intensity of itching can be reduced by improving skin hydration through the application of body lotion. This study aims to determine the ability of body lotion enriched with provitamin D3 to reduce the intensity of itching in patients with CKD undergoing routine HD.
Who can participate?
CKD patients aged 18-60 years old who have undergone routine hemodialysis two times a week for between 3 months and 10 years, and who have complaints of pruritus
What does the study involve?
Participants would be instructed to apply the randomly assigned body lotion twice a day and to sunbathe twice a week for 4 weeks. A nurse would draw 3 ml of blood at the beginning and the end of the study. Itching intensity and skin hydration are measured at the beginning and after 2, and 4 weeks.
What are the possible benefits and risks of participating?
The possible benefits would be free body lotions and free measurement of skin hydration, vitamin D levels, and IL-31 levels. The possible risks of using body lotion could be itchy, stinging, and/or pain at the site of application, while the risks of venous blood sampling could be phlebitis (inflammation of a vein) and/or thrombophlebitis (blood clot in a vein) at the sampling site
Where is the study run from?
Gadjah Mada University (Indonesia)
When is the study starting and how long is it expected to run for?
November 2021 to June 2023
Who is funding the study?
1. Duta Wacana Christian University (Indonesia)
2. Gadjah Mada University (Indonesia)
Who is the main contact?
Dr Arum Krismi, M.Sc, Sp.KK, penelitian.arumkrismi@gmail.com
Contact information
Principal Investigator
Sekar Bakung Residence no. E1
Jl. Imogiri Barat, Semail, Kel. Bangunharjo, Kec. Sewon, Daerah Istimewa Yogyakarta
Bantul
55188
Indonesia
 ORCID ID |
0000-0003-4276-3025 |
|---|---|
| Phone | +62 (0)811254861 |
| dr_arumkrismi@staff.ukdw.ac.id |
Study information
| Study design | Multicenter interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42961_PIS_05Jan23.pdf |
| Scientific title | Correlation of changes in pruritus intensity with changes in serum IL-31 levels after application of body lotion enriched with provitamin D3 on patients with chronic kidney disease undergoing routine hemodialysis |
| Study objectives | Body lotion enriched with provitamin D3 reduced the intensity of chronic kidney disease-associated pruritus on patients undergoing routine hemodialysis |
| Ethics approval(s) | Approved 23/12/2021, Medical and Research Ethics Committee (MHREC) Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada-Dr. Sardjito General Hospital (Gedung Radiopoetro Lt 2 Sayap Barat, Jl. Farmako, Sekip Utara, Yogyakarta, Indonesia, 55128; +62 (0)274 588688 ext. 17225, +62 (0)811 2666 869; mhrec_fmugm@ugm.ac.id), ref: KE/FK/1375/EC/2021 |
| Health condition(s) or problem(s) studied | Chronic kidney disease-associated pruritus in patients undergoing routine hemodialysis |
| Intervention | Treatment: body lotion enriched with and without (placebo) provitamin D3 Randomization: simple randomization Details of interventions: 1. 4 g (equal to 20,000 IU provitamin D3) per day, applied to one arm (1.5 g per application) and about 10 cm² area with the most intense itching (0.5 g per application), applied twice daily after bathing, for 28 days 2. Sunbathing twice weekly on the applicated arm |
| Intervention type | Supplement |
| Primary outcome measure | Pruritus intensity measured using a 24-hours Worst Itching Intensity Visual Analog Scale (WI-VAS) at baseline, 2, and 4 weeks |
| Secondary outcome measures | 1. Transepidermal water loss measured using a Tewameter at baseline, 2, and 4 weeks 2. Stratum corneum hydration measured using a corneometer at baseline, 2, and 4 weeks 3. Serum calcidiol levels measured using ELISA at baseline and 4 weeks 4. Serum IL-31 levels measured using ELISA at baseline and 4 weeks |
| Overall study start date | 08/11/2021 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 82 |
| Total final enrolment | 61 |
| Key inclusion criteria | 1. 18-60 years old 2. Complaints of pruritus with WI-VAS ≥4 3. Undergoing routine hemodialysis two times a week for ≥3 months and ≤10 years 4. Do not use any topical medical treatment for pruritus for at least 2 weeks before the study started. Medical treatment is medicine given by a doctor, both recorded in the Medical Record (MR) of the subject or recorded by the subject 5. Do not use any self-medication that is topically applied for pruritus for at least 2 weeks before the start of the study. Self-medication is non-medical treatment carried out by the subject alone or given by family, including but not limited to herbal concoctions, special soaps, oils, powders, and others 6. Agree to voluntarily participate in the study by signing the informed consent form |
| Key exclusion criteria | 1. Having one or more of the following diseases listed in subject MR and or obtained from anamnesis during subject screening: 1.1. Hepatitis C virus infection 1.2. Primary biliary cirrhosis 1.3. Hodgkin lymphoma 1.4. Cutaneous T-cell lymphoma 1.5. Polycythemia vera 1.6. HIV infection 1.7. Atopic dermatitis 1.8. Drug-induced hypersensitivity 1.9. Insect bites reactions 1.10. Scabies 2. Having an impaired verbal and written communication 3. Having an impaired mobility |
| Date of first enrolment | 10/05/2022 |
| Date of final enrolment | 06/05/2023 |
Locations
Countries of recruitment
- Indonesia
Study participating centres
Yogyakarta
55223
Indonesia
Sleman
55281
Indonesia
Yogyakarta
55224
Indonesia
Yogyakarta
55122
Indonesia
Sleman
55291
Indonesia
Sleman
55294
Indonesia
Yogyakarta
55162
Indonesia
Sponsor information
University/education
Prodi Doktor FK-KMK UGM
Gedung Pascasarjana Tahir, Sayap Utara lantai 3
Jl. Farmako, Sekip Utara, Sendowo, Sinduadi, Mlati, Daerah Istimewa Yogyakarta
Sleman
55281
Indonesia
| Phone | +62 (0)274 545458 |
|---|---|
| s3fk@ugm.ac.id | |
| Website | https://s3.fkkmk.ugm.ac.id/ |
"ROR" |
https://ror.org/03ke6d638 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Duta Wacana Christian University, UKDW Yogyakarta, UKDW, DWCU
- Location
- Indonesia
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Gadjah Mada University, UGM
- Location
- Indonesia
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in 'Advances in Chronic Kidney Disease' |
| IPD sharing plan | The datasets generated and/or analysed during the current study are/will be available upon request from Arum Krismi (dr_arumkrismi@staff.ukdw.ac.id). The type of data will be shared as requested in the format of excel, when all of the results are already published for about 5 years since the end of the study, to view only, with other researchers of the same field of study (CKD-associated pruritus), without consent from participants because the data would not contain participants' identity except their age and sex. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 05/01/2023 | 05/01/2023 | No | Yes |
Additional files
Editorial Notes
16/01/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The study participating centre RSUD Sleman was removed.
05/01/2023: Trial's existence confirmed by the Medical & Health Research Ethics committee (MHREC) Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada.
