1. Home
  2. Approved trials
  3. » فارسی

The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial

View the latest revision

History
# Registration date Revision Id
4 2026-10-28, 1405/08/06 401525
3 2026-10-27, 1405/08/05 401352
2 2026-10-18, 1405/07/26 400292
1 2025-03-27, 1404/01/07 334655
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • General information

    The expected start date of participant recruitment was inadvertently entered in the IRCT registration form as approximately three months earlier than the actual date of trial registration. However, participant recruitment did not begin until after the trial had been registered with IRCT. This discrepancy has caused difficulties in submitting manuscripts arising from this trial, as journals have interpreted the study as a retrospectively registered clinical trial. We would therefore kindly request that the expected start date of participant recruitment be amended from 1403/12/10 to 1404/03/01 and the expected end date from 1405/01/31 to 1405/03/01 to accurately reflect the intended recruitment period
    Please record the actual start date of data collection (May 23, 2025) and the actual end date of data collection (July 11, 2026) in the Iranian Registry of Clinical Trials for trial ID IRCT20250110064340N1.
    به علت اینکه تاریخ شروع نمونه گیری حدود یک ماه قبل از تاریخ ثبت IRCT در فرم به اشتباه ثبت شده (با وجود اینکه نمونه گیری پس از ثبت IRCT گرفته شده است ) ارسال مقاله حاصل از این کار ازمایی با مشکل مواجه شده و مجلات این کار ازمایی را به عنوان کار ازمایی گذشته نگر در نظر می گیرند،خواهشمند است تاریخ شروع نمونه گیری مورد انتظار در فرم را از تاریخ ۱۴۰۳/۱۲/۱۰ به ۱۴۰۴/۳/۱تغییر و پایان نمونه گیری به تاریخ ۱۴۰۵/۳/۱تغییر یابد.
    لطفاً تاریخ واقعی شروع جمع‌آوری داده‌ها (۱۴۰۴/۰۳/۰۲) و تاریخ واقعی پایان جمع‌آوری داده‌ها (۱۴۰۵/۰۴/۲۰) را در سامانه ثبت کارآزمایی بالینی ایران برای شناسه IRCT20250110064340N1 ثبت فرمایید

  • Intervention groups

    #1
    گروه کنترل: روزاﻧﻪ ۲ ﻋﺪد ﮐﭙﺴﻮل داروﻧﻤﺎ ﻧﺎﻧﻮ ﮐﻮرﮐﻮﻣﯿﻦ و ﻫﻔﺘﻪ ای ﯾﮏ ﻋﺪد داروﻧﻤﺎ وﯾﺘﺎﻣﯿﻦD،ﺑﻪ ﻣﺪت ۸ ﻫﻔﺘﻪ درﯾﺎﻓﺖ ﺧﻮاﻫﻨﺪ ﮐﺮد. داروﻧﻤﺎی وﯾﺘﺎﻣﯿﻦ D ﺣﺎوی ﭘﺎراﻓﯿﻦ ﺧﻮراﮐﯽ ﮐﻪ از ﻧﻈﺮ ﺷﮑﻞ و رﻧﮓ ﺷﺒﯿﻪ ﻗﺮص وﯾﺘﺎﻣﯿﻦ D اﺳﺖ . کارخانه سازنده:شرکت زهراوی-تهران داروﻧﻤﺎی ﮐﻮرﮐﻮﻣﯿﻦ ﺣﺎوی ﻟﺴﺘﯿﻦ و رﻧﮓ زرد ﺧﻮراﮐﯽ E۱۰۴ ﮐﻪ از ﻧﻈﺮ ﺷﮑﻞ و رﻧﮓ ﺷﺒﯿﻪ ﻗﺮص ﮐﻮرﮐﻮﻣﯿﻦ اﺳﺖ
    گروه کنترل: روزاﻧﻪ ۲ ﻋﺪد ﮐﭙﺴﻮل داروﻧﻤﺎ ﻧﺎﻧﻮ ﮐﻮرﮐﻮﻣﯿﻦ و ﻫﻔﺘﻪ ای ﯾﮏ ﻋﺪد داروﻧﻤﺎ وﯾﺘﺎﻣﯿﻦD، ﺑﻪ ﻣﺪت ۸ ﻫﻔﺘﻪ درﯾﺎﻓﺖ ﺧﻮاﻫﻨﺪ ﮐﺮد. داروﻧﻤﺎی وﯾﺘﺎﻣﯿﻦ D ﺣﺎوی ﭘﺎراﻓﯿﻦ ﺧﻮراﮐﯽ ﮐﻪ از ﻧﻈﺮ ﺷﮑﻞ و رﻧﮓ ﺷﺒﯿﻪ ﻗﺮص وﯾﺘﺎﻣﯿﻦ D اﺳﺖ . کارخانه سازنده:شرکت زهراوی-تهران داروﻧﻤﺎی ﮐﻮرﮐﻮﻣﯿﻦ ﺣﺎوی ﻟﺴﺘﯿﻦ و رﻧﮓ زرد ﺧﻮراﮐﯽ E۱۰۴ ﮐﻪ از ﻧﻈﺮ ﺷﮑﻞ و رﻧﮓ ﺷﺒﯿﻪ ﻗﺮص ﮐﻮرﮐﻮﻣﯿﻦ اﺳﺖ

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Jalil Masoumi
    Full name of responsible person - Persian: سید جلیل معصومی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nutrition and Food Sciences, Opposite Bargh Sports Club, Razi Blvd
    Street address - Persian: بولوار رازی،روبروی باشگاه ورزشی برق،دانشکده تغذیه و علوم غذایی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675500
    Phone: +98 71 3725 1001
    Mobile: +98 917 315 0269
    Fax:
    Email: scnutrition@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Jalil Masoumi
    Full name of responsible person - Persian: سید جلیل معصومی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nutrition and Food Sciences, Opposite Bargh Sports Club, Razi Blvd
    Street address - Persian: بولوار رازی، روبروی باشگاه ورزشی برق، دانشکده تغذیه و علوم غذایی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675500
    Phone: +98 71 3725 1001
    Mobile: +98 917 315 0269
    Fax:
    Email: scnutrition@sums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Marzieh zamani
    Full name of responsible person - Persian: مرضیه زمانی
    Position - English: PHD student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nutrition and Food Sciences, Opposite Bargh Sports Club, Razi Blvd
    Street address - Persian: بولوار رازی،روبروی باشگاه ورزشی برق،دانشکده تغذیه و علوم غذایی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675500
    Phone: +98 71 3725 1001
    Mobile: +98 917 711 2633
    Fax:
    Email: mzamani.dmm@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Marzieh zamani
    Full name of responsible person - Persian: مرضیه زمانی
    Position - English: PHD student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nutrition and Food Sciences, Opposite Bargh Sports Club, Razi Blvd
    Street address - Persian: بولوار رازی، روبروی باشگاه ورزشی برق، دانشکده تغذیه و علوم غذایی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675500
    Phone: +98 71 3725 1001
    Mobile: +98 917 711 2633
    Fax:
    Email: mzamani.dmm@gmail.com
    Web page address:

Protocol summary

Study aim
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
Please record the actual start date of data collection (May 23, 2025) and the actual end date of data collection (July 11, 2026) in the Iranian Registry of Clinical Trials for trial ID IRCT20250110064340N1.
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20250110064340N1
Registration date: 2025-03-27, 1404/01/07
Registration timing: prospective

Last update: 2026-10-28, 1405/08/06
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
2025-05-21, 1404/02/31
Expected recruitment end date
2026-05-21, 1405/02/31
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
Ethics Committee of Shiraz University of Medical Sciencesal Science
Street address
Shiraz University of Medical Sciences, Zand Blvd
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
Station 11, Farhang Shahr
City
shiraz
Province
Fars
Postal code
7187915998
Phone
+98 71 3632 3532
Fax
+98 71 3632 5655
Email
amirhosp@sums.ac.ir
Web page address
https://amirhosp.sums.ac.ir

2

Recruitment center
Name of recruitment center
Mehr Oncology Clinic, Shahid Chamran Hospital
Full name of responsible person
Reza Vojdani
Street address
Mehr Oncology Clinic, Shahid Chamran Hospital, Shahid Chamran Blvdl
City
shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Fax
+98 71 3623 4507
Email
chamranlb1@sums.ac.ir
Web page address
https://shirazchamranhospital.com

3

Recruitment center
Name of recruitment center
Pardis clinic
Full name of responsible person
Mahnaz Lotfi
Street address
intersection of Bahonar South, Rahmat Blvd
City
shiraz
Province
Fars
Postal code
7176758399
Phone
+98 71 9100 2030
Email
dr.mahnaz.lotfi@gmail.com
Web page address
https://en.pardiscancer.com

4

Recruitment center
Name of recruitment center
Hazrat Abolfazl Chemotherapy Unit
Full name of responsible person
Mohamad Mohamadyan panah
Street address
Hazrat Abolfazl Chemotherapy Unit, Next to Namazi Hospital, Namazi Square
City
shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
Emamrezalab@sums.ac.ir
Web page address
https://namazi.sums.ac.ir

5

Recruitment center
Name of recruitment center
Motahairi clinic
Full name of responsible person
Reza Vojdani
Street address
Shahid Motahari Clinic, Next to Namazi Hospital, Namazi Square
City
shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
motaharilab@sums.ac.ir
Web page address
https://emamreza.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
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
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
Loading...