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

Not Applicable

Completed

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

• Registration Number: ISRCTN27942151
• Lead Sponsor: Gadjah Mada University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-06
• Study Completion: 2023-06-30
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 1. Transepidermal water loss measured using a Tewameter at baseline, 2, and 4 weeks<br> 2. Stratum corneum hydration measured using a corneometer at baseline, 2, and 4 weeks<br> 3. Serum calcidiol levels measured using ELISA at baseline and 4 weeks<br> 4. Serum IL-31 levels measured using ELISA at baseline and 4 weeks<br>