Home » Trials » SLCTR/2024/016
The effect of vitamin D supplementation on quality of life in stage II-III colorectal cancer patients undergoing adjuvant chemotherapy at Hasan Sadikin Hospital: A single-blind, randomized control trials
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SLCTR Registration Number
SLCTR/2024/016
Date of Registration
The date of last modification
May 07, 2024
Scientific Title of Trial
The effect of vitamin D supplementation on quality of life in stage II-III colorectal cancer patients undergoing adjuvant chemotherapy at Hasan Sadikin Hospital: A single-blind, randomized control trials
Public Title of Trial
The effect of vitamin D supplementation compared to placebo on quality of life in stage II-III colorectal cancer patients undergoing adjuvant chemotherapy at Hasan Sadikin Hospital: A single-blind, randomized control trial.
Disease or Health Condition(s) Studied
Colorectal Cancer
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1302-6499
Any other number(s) assigned to the trial and issuing authority
LB.02.01/X.6.5/129/2023
What is the research question being addressed?
What is the effect of vitamin D supplements on the quality of life in patients with stage II-III colorectal cancer undergoing adjuvant chemotherapy at Hasan Sadikin Hospital compared to placebo?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Placebo
Assignment
Parallel
Purpose
Supportive care
Study Phase
Phase 0 (exploratory trials)
Intervention(s) planned
Setting: Hasan Sadikin Hospital. Method of randomization: Simple randomization. Method of concealment: sealed opaque envelopes. Intervention: vitamin D 10,000 IU/day for six months. Placebo: water injected capsule.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Level of Vitamin D and EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30) score which contains 5 domains (Role, Physical, Cognitive, Emotional, and Social) |
[ 3- and 6-months post intervention ] |
Secondary outcome(s)
Target number/sample size
70 (35 in each arm)
Countries of recruitment
Indonesia
Anticipated start date
2024-06-01
Anticipated end date
2025-06-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
PT. Imedco Djaja, pharmaceutical industry
Regulatory approvals
Status
Approved
Date of Approval
2023-12-10
Approval number
LB.02.01/X.6.5/129/2023
Details of Ethics Review Committee
| Name: | Health Research Ethics Committee RSUP |
| Institutional Address: | Pasteur No. 38, Bandung, Indonesia |
| Telephone: | 62222034953 |
| Email: | rsup@rshs.web.id |
Contact person for Scientific Queries/Principal Investigator
Tovan Perinandika
General Surgeon
Pasteur No. 38, Bandung, Indonesia
628122041399
tovan19001@mail.unpad.ac.id
Contact Person for Public Queries
Tovan Perinandika
General Surgeon
Pasteur No. 38, Bandung, Indonesia
628122041399
tovan19001@mail.unpad.ac.id
Primary study sponsor/organization
Andy
Pharmaceutical Administrator
Raya Serang KM 25 No. 8, Balaraja, Banten, Indonesia
628129266770
https://imedco-djaja.com/id/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
