Skip to content

The ability of body lotion containing provitamin D3 to reduce itching in patients with chronic kidney disease undergoing routine hemodialysis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27942151
Enrollment
82
Registered
2023-01-06
Start date
2022-05-10
Completion date
Unknown
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease-associated pruritus in patients undergoing routine hemodialysis Skin and Connective Tissue Diseases Pruritus

Interventions

Treatment: body lotion enriched with and without (placebo) provitamin D3 Randomization: simple randomization Details of interventions: 1. 4 g (equal to

Sponsors

Gadjah Mada University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Pruritus intensity measured using a 24-hours Worst Itching Intensity Visual Analog Scale (WI-VAS) at baseline, 2, and 4 weeks

Secondary

MeasureTime frame
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

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026