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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.

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2024/016
Enrollment
Unknown
Registered
2024-05-07
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Colorectal Cancer

Interventions

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

Sponsors

Andy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients diagnosed with colorectal cancer based on the WHO histopathological classification system. 2. All stage II-III colorectal cancer patients undergoing adjuvant chemotherapy at Hasan Sadikin Hospital from May 2024 to April 2025. 3. Patients above 18 years of age.

Exclusion criteria

Exclusion criteria: 1. The patient has consumed vitamin D supplements in the last three months. 2. Allergy to vitamin D supplements. 3. The patient has a primary cancer other than colorectal cancer. 4. Patients with short bowel syndrome or patients undergoing gastric bypass surgery. 5. The patient regularly consumes phenobarbital, carbamazepine, dexamethasone, nifedipine, spironolactone, clotrimazole and rifampicin groups. 6. Patient with symptoms of genitourinary stones in the past year. 7. Patient is consuming a thiazide diuretic. 8. Patient with chronic non-infectious disease (liver failure and kidney failure, history of stroke, type I and II diabetes mellitus). 9. Patients with chronic infectious disease (infection lasts >6 months), such as HIV infection, tuberculosis, hepatitis C, HPV, et cetera. 10. Patients who are pregnant, breastfeeding or using oral contraceptives.

Design outcomes

Primary

MeasureTime frame
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]

Countries

Indonesia

Contacts

Public ContactTovan Perinandika

General Surgeon

tovan19001@mail.unpad.ac.id

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026