The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial
Determining the effect of curcumin and vitamin D supplementation on inflammatory biomarkers and nutritional status of patients with colorectal cancer
Design
A randomized, double-blind, parallel-group, controlled clinical trial on 92 patients with colorectal cancer. Randomization was performed using random allocation software with a block size of 4 and a ratio of 1:1:1:1.
Settings and conduct
Patients with colorectal cancer referred to Amir Hospital, Mehr Clinic, Pardis Clinic, Hazrat Abolfazl Chemotherapy Center, and Motahari Clinic will be included in the study through convenience sampling method upon informed consent, according to the inclusion criteria and the absence of exclusion criteria. Blinding: The appearance, packaging, color, and size of the supplements and the dosage will be similar. At the beginning and end of the study, inflammatory factors, hand muscle strength, quality of life questionnaire, body composition analysis, and dietary components will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Colorectal cancer patients
At least 3-month life expectancy
Using chemotherapy method
Nonallergic to turmeric
Exclusion criteria:
Unwillingness to participate in the study
Not continuing chemotherapy
Intervention groups
Curcumin group: 80 mg of nanocurcumin daily and one placebo vitamin D tablet per week; Vitamin D group: one tablet of vitamin D (50,000) per week and two placebo nanocurcumin tablets per week; Curcumin and vitamin D group: 80 mg of nanocurcumin daily and one tablet of vitamin D (50,000) per week; Placebo group: Two tablets of curcumin daily and one placebo vitamin D tablet per week.
Main outcome variables
Interleukin 6, tumor necrosis factor alpha, C-reactive protein to albumin ratio, quality of life, body fat, lean body mass, body mass index, hand muscle strength, basal metabolism, dietary components
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20250110064340N1
Registration date:2025-03-27, 1404/01/07
Registration timing:registered_while_recruiting
Last update:2025-03-27, 1404/01/07
Update count:3
Registration date
2025-03-27, 1404/01/07
Registrant information
Name
Marzieh Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 2710
Email address
mzamani.dmm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-28, 1403/12/10
Expected recruitment end date
2025-11-01, 1404/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial
Public title
The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with colorectal cancer
18-60 years of age
At least 3 months of life expectancy
Using chemotherapy
BMI=18-30 kg/m2
Nonallergic to turmeric
Not suffering from hypertension or renal, hepatic, or parathyroid disorders
Exclusion criteria:
Unwillingness to participate in the study
Not continuing chemotherapy
Fever greater than 38.5°C in three days before receiving the first dose of the supplementary drugs
Known positive HIV serology
Patients with other malignancies, Pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
92
More than 1 sample in each individual
Number of samples in each individual:
23
Curcumin group: This group will receive 2 capsules of 40 mg of nanocurcumin daily (80 mg daily) and a placebo of vitamin D (500,000 IU) once a week, for 8 weeks. Vitamin D group: This group will receive one vitamin D tablet (500,000IU) weekly, and two placebo capsules (40 mg of nanocurcumin) daily (80 mg daily), for 8 weeks. Curcumin + Vitamin D group: This group will receive 2 capsules of 40 mg of Nano-curcumin (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly, for 8 weeks. Curcumin + Vitamin D group: This group will receive 2 capsules of 40 mg of Nano-curcumin (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly, for 8 weeks
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software with a block size of 4 and a ratio of 1:1:1:1,
the groups assigned to each participant will be labeled as A, B, C, D in identical sealed envelopes by an outsider.
Blinding (investigator's opinion)
Double blinded
Blinding description
The appearance, packaging, color, and size of the supplements and placebos will be similar. The supplements and placebos will be labeled by an outsider in line with the names of the groups with letters A, B, C, and D. Therefore, both the participants and the researcher will be unaware of the study groups and the use of the drug and placebo until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
The intervention will last for 8 weeks. The study participants will be divided into four groups:1- Curcumin group; 2- Vitamin D group; 3- Curcumin and vitamin D group; 4- Placebo group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shiraz university of medical science
Street address
Shiraz. Karim Khan Zand Boulevard
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-10-13, 1403/07/22
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1403.063
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
Tumor necrosis factor alpha
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
Method of measurement
Using laboratory kit and ELISA method
2
Description
Interleukin 6
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
Method of measurement
Using laboratory kit and ELISA method
3
Description
C-reactive protein to albumin ratio
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
Method of measurement
Using a laboratory kit
4
Description
Hand muscle strength
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
Method of measurement
Using handgrip
5
Description
Quality of life
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
Method of measurement
Quality of life questionnaire
6
Description
Body mass index, basal metabolic rate, fat mass, fat-free mass, weight
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
Method of measurement
Using BIA
7
Description
Dietary components include energy, carbohydrates, protein, fat, and fiber
Timepoint
At the beginning of the study (before the intervention), 4 weeks after taking curcumin and vitamin D and 8 weeks after taking curcumin and vitamin D
Method of measurement
Using a 24-hour food recall questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Curcumin group: They will receive 2 capsules of 40 mg of nano-curcumin daily (80 mg daily) and one vitamin D placebo weekly for 8 weeks. Manufacturer: Exir Nano Sina Company-Tehran
Category
Treatment - Drugs
2
Description
Second intervention group: Vitamin D group: They will receive one vitamin D tablet (50000IU) per week and 2 nanocurcumin placebo capsules per day. Manufacturer: Zahravi Company-Tabriz
Category
Treatment - Drugs
3
Description
The third intervention group (Curcumin + Vitamin D group): Two capsules of 40 mg of nano-curcumin daily (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly for 8 weeks
Category
Treatment - Drugs
4
Description
Control group: This group will receive two capsules of the nanocurcumin placebo daily and one capsule of the vitamin D placebo weekly for 8 weeks. The vitamin D placebo contains food grade paraffin, which is similar in shape and color to a vitamin D tablet. Manufacturer: Zahravi Company, Tabriz The curcumin placebo contains lecithin and food grade yellow dye E104, which is similar in shape and color to a curcumin tablet. Manufacturer: Exir Nano Sina Company, Tehran
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Reza Vojdani
Street address
Shiraz, Farhang Shahr, Station 11
City
shiraz
Province
Fars
Postal code
07187915998
Phone
+98 71 3632 3532
Fax
+98 71 3632 5655
Email
amirhosp@sums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Chamran Hospital, Mehr Oncology Clinic
Full name of responsible person
Reza Vojdani
Street address
Shahid Chamran Blvd, Shahid Chamran Hospital, Mehr Oncology Clinic
City
shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Fax
+98 71 3623 4507
Email
chamranlb1@sums.ac.ir
3
Recruitment center
Name of recruitment center
pardis clinic
Full name of responsible person
Mahnaz Lotfi
Street address
Bahonar Crossroads. Rahmat Boulevard Intersection
City
shiraz
Province
Fars
Postal code
7176758399
Phone
+98 71 9100 2030
Email
dr.mahnaz.lotfi@gmail.com
4
Recruitment center
Name of recruitment center
Hazrat Abolfazl Chemotherapy Unit
Full name of responsible person
Mohamad Mohamadyan panah
Street address
Namazi Square, next to Namazi Hospital, Hazrat Abolfazl Chemotherapy Unit
City
shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
Emamrezalab@sums.ac.ir
5
Recruitment center
Name of recruitment center
Mohairi clinic
Full name of responsible person
Reza Vojdani
Street address
Namazi Square, next to Namazi Hospital, Shahid Motahari Clinic
City
shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
motaharilab@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
seyed jalil masoumi
Street address
Razi Boulevard, opposite Barg Sports Club, Faculty of Nutrition and Food Sciences
City
shiraz
Province
Fars
Postal code
7153675500
Phone
+98 71 3725 1001
Email
scnutrition@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Zamani
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Opposite Bargh Sports club, Razi Blvd
City
shiraz
Province
Fars
Postal code
7156675500
Phone
+98 71 3725 1001
Email
mzamani.dmm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Jalil Masoumi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Opposite Bargh Sports Club, Razi Blvd
City
shiraz
Province
Fars
Postal code
7153675500
Phone
+98 71 3725 1001
Email
scnutrition@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh zamani
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Opposite Bargh Sports Club, Razi Blvd
City
shiraz
Province
Fars
Postal code
7153675500
Phone
+98 71 3725 1001
Email
mzamani.dmm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available