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The effect of vitamin D3 supplementation (cholecalciferol) on nutritional status, VDR gene expression, endocrine, metabolic, and adipokine parameters in patients with benign breast tumors:Randomized controlled clinical trial

Protocol summary

Study aim
Determination of the effect of vitamin D3 (cholecalciferol) supplementation on nutritional status, gene expression, VDR, endocrine parameters, metabolic parameters, and adipokines in patients with benign breast tumors
Design
The patients will be classified into two intervention groups (receivers of vitamin D and placebo receivers of oral liquid paraffin) based on age, BMI, and benign type (fibrocystic masses and fibroadenomas), provided that they have no malignant characteristics confirmed by ultrasound examination.
Settings and conduct
The current study is a randomized controlled clinical trial. Random sampling will be conducted using a random number table, and the selected samples will be allocated to each block and group. The study will be conducted in a triple-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria:histopathological evidence of BBT,age between 19 and 50 years,serum vitamin D deficiency,at least two years since diagnosis, willingness to cooperate and complete the informed consent form. Exclusion criteria:Malabsorption disorders,biliary tract obstruction, acute or chronic conditions, hyperthyroidism, hormonal disorders,type 1 diabetes, hypoglycemia,grade 3 obesity,a daily calorie intake of less than 500 or more than 3500 kcal/d,cystectomy,asthma, any benign lesions in other organs, pregnancy and lactation,chemotherapy,radiotherapy, or hormone therapy, use of glucocorticoid, anti-seizure, contraceptive, and HRT medications,fish liver oil more than 2000 mg per day،caffeinated pain reliever
Intervention groups
In the intervention group, patients will receive one pearl of vitamin D3 50,000 IU per week for 8 weeks. In the control group, patients will receive one pearl of oral liquid paraffin per week for 8 weeks.
Main outcome variables
nutritional status, VDR gene expression, endocrine, metabolic, and adipokine parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100209003320N24
Registration date: 2024-07-18, 1403/04/28
Registration timing: registered_while_recruiting

Last update: 2024-07-18, 1403/04/28
Update count: 0
Registration date
2024-07-18, 1403/04/28
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D3 supplementation (cholecalciferol) on nutritional status, VDR gene expression, endocrine, metabolic, and adipokine parameters in patients with benign breast tumors:Randomized controlled clinical trial
Public title
The effect of vitamin D3 on benign breast tumor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Histopathological evidence of BBT (fibrocystic, fibroadenoma, etc.) Age between 19 and 50 years At least two years since diagnosis willingness to cooperate and complete the informed consent form Serum vitamin D deficiency (less than 20 ng/ml)
Exclusion criteria:
Malabsorption disorders (such as Crohn's disease, celiac disease), biliary tract obstruction Acute or chronic conditions (including various types of cancer, liver, kidney, and acute heart failure), hyperthyroidism, hormonal disorders prior to diagnosis (e.g., polycystic ovary syndrome (PCOS)), type 1 diabetes, hypoglycemia, adrenal gland disorders Grade 3 obesity A daily calorie intake of less than 800 or more than 3500 kcal/d Asthma Any benign lesions in other organs Pregnancy Lactation Chemotherapy Radiotherapy Hormone therapy Cystectomy surgery Use of glucocorticoid, anti-seizure, contraceptive, and HRT medications Consuming more than 2000 mg of cod liver oil Taking painkillers containing caffeine
Age
From 19 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be classified into two intervention groups (receivers of vitamin D and placebo receivers of oral liquid paraffin) based on age, BMI, and benign type (fibrocystic masses and fibroadenomas), provided that they have no malignant characteristics confirmed by ultrasound examination. Random sampling will be conducted using a random number table, and the selected samples will be allocated to each block and group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is designed as a triple-blind trial. Initially, random selection of the samples is conducted by the study designer, and a list is prepared. Then, the clinic staff, who are unaware of the allocation at the time of enrollment, execute this list. Participants are randomly assigned to two groups: those receiving the vitamin D supplement and those receiving the placebo (oral liquid paraffin). Blinding procedure: Participants: Are unaware of the type of supplement they receive (vitamin D or paraffin). Clinic staff: Responsible for delivering the supplements and placebos, and the packages are delivered in a uniform manner without any distinguishing labels. Laboratory personnel: Who analyze the test results, are unaware of the participants' group allocations. The supplement and placebo packages are prepared and distributed uniformly without any indication of their contents. Allocation codes are kept with the principal investigator until the end of the study, and none of the individuals involved in the study's execution are aware of these codes to minimize bias.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2024-06-12, 1403/03/23
Ethics committee reference number
IR.TBZMED.REC.1403.183

Health conditions studied

1

Description of health condition studied
Benign breast disease
ICD-10 code
D24
ICD-10 code description
Benign neoplasm of breast

Primary outcomes

1

Description
VDR gene expression
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
Real time RT-PCR

2

Description
Endocrine parameters
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
ELIZA

3

Description
Metabolic parameters
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
Enzymatic kits

4

Description
Adipokines
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
ELIZA

Secondary outcomes

1

Description
Nutritional status
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
A 24-hour dietary recall in three days (one holiday and two working days) and valid food frequency questionnaire

2

Description
Physical activity
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
Physical activity questionnaire

3

Description
Anthropometric status
Timepoint
Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
Centimeter, Scale

Intervention groups

1

Description
Intervention group:Consume one pearl of vitamin D3 50,000 IU per week for 8 weeks. Participants will be advised to maintain their usual lifestyle, including their habitual diet.All participants will begin a two-week run-in period before starting the intervention. During this period, participants are asked not to be exposed to direct sunlight for more than 15 minutes a day. Also, they are asked not to consume eggs more than twice a week. Patients are also advised to avoid sources of omega-3 oils, nuts (such as almonds and walnuts), fatty fish, and cod liver. Avoid foods containing methylxanthine, vitamin E supplement, evening primrose oil during this period and until the end of the study.All participants will receive calcium carbonate (500 mg) together with cholecalciferol (200 IU) (Ca/VitD) from the beginning to the end of the study
Category
Treatment - Other

2

Description
Control group: One pearl of oral liquid paraffin per week for 8 weeks. In the control group, patients will receive one pearl of oral liquid paraffin per week for 8 weeks. The appearance of the placebo capsules will be identical to the vitamin D capsules in terms of color, shape, size, and packaging. Both vitamin D and placebo capsules will be obtained from Zahravi Pharmaceutical Company.Participants will be advised to maintain their usual lifestyle, including their habitual diet.All participants will begin a two-week run-in period before starting the intervention. During this period, participants are asked not to be exposed to direct sunlight for more than 15 minutes a day. Also, they are asked not to consume eggs more than twice a week. Patients are also advised to avoid sources of omega-3 oils, nuts (such as almonds and walnuts), fatty fish, and cod liver. Avoid foods containing methylxanthine, vitamin E supplement, evening primrose oil during this period and until the end of the study.All participants will receive calcium carbonate (500 mg) together with cholecalciferol (200 IU) (Ca/VitD) from the beginning to the end of the study.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sceinces
Full name of responsible person
Dr. Mehrangiz Ebrahimi-Mamagani
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3177 1041
Email
ebrahimimamagani@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahdieh Abbasalizad Farhangi
Street address
Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14711
Phone
+98 41 3335 7582
Email
abbasalizadm@tbzmed.ac.ir
Grant name
Tabriz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi- Mameghani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
ebrahimimamagani@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi- Mameghani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3335 7584
Email
ebrahimimamagani@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Asemani
Position
PhD Candidate in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
asemanisanaz65@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
The access period starts 12 months after the results are published
To whom data/document is available
The data will be available only to people working in scientific institutions
Under which criteria data/document could be used
The data of this study will be available to other researchers only for meta-analysis studies
From where data/document is obtainable
Sanaz Asemani, email adress:asemanisanaz65@gmail.com Phon number: 09038553148
What processes are involved for a request to access data/document
The applicant should provide a brief description of the aims and methods of Meta-analysis. His/her request will be assessed and, if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days.
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