Protocol summary

Study aim
Comparison of the effects of vitamin D and N-acetylcysteine supplementation on the expression of cellular senescence genes and inflammatory factors in the elderly with vitamin D deficiency.
Design
The clinical trial has 4 intervention groups, with parallel, double-blind, randomized groups, with a sample size of 100 elderly people with vitamin D deficiency. Random allocation will be done in the form of Stratified Randomization.
Settings and conduct
Elderly people with vitamin D deficiency will be classified into one of the four study groups. Before and after the intervention, blood samples will be taken from them and biochemical, molecular and staining tests will be done on the sample.
Participants/Inclusion and exclusion criteria
Elderly people with a body mass index of 25-32 kg/m2; Serum vitamin D deficiency (less than 30 ng/mL); Age over 65 years old; Absence of chronic and acute inflammatory and infectious diseases; No diabetes and thyroid diseases; Absence of Alzheimer's and dementia; No alcohol and smoking; Lack of medication or a disorder that affects vitamin D metabolism (anticonvulsant drugs, antituberculosis drugs, glucocorticoids, HIV drugs). Not receiving vitamin D, NAC and antioxidant supplements in the last three months; Non-participation in other clinical trial studies at the same time as the present study. Exclusion critria: Hypercalcemia (more than 2.6 mmol/L), dysparathyroidism, kidney failure and stones, and long-term treatment with bisphosphonates and corticosteroids. Consumption of less than 90% of prescribed supplements  Unwillingness to cooperate during the intervention.
Intervention groups
Group 1. NAC 600 mg/d + 1000 IU/d vitamin D Group 2. 5000 IU/d vitamin D Group 3. NAC 600 mg/d + 5000 IU/d vitamin D Group 4. 1000 IU/d vitamin D.
Main outcome variables
Gene expression of p21, p16, IL-6, β-galactosidase activity, serum IL-6, CRP and TNFα

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230508058120N1
Registration date: 2023-08-20, 1402/05/29
Registration timing: prospective

Last update: 2023-08-20, 1402/05/29
Update count: 0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Samira Rastgoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7483
Email address
samiraa.rastgoo@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of vitamin D and N-acetylcysteine supplementation on the expression of cellular senescence genes and inflammatory factors in the elderly with vitamin D deficiency. A double-blind randomized clinical trial
Public title
Comparison of the effects of vitamin D and N-acetylcysteine supplementation on the expression of cellular senescence genes and inflammatory factors in the elderly with vitamin D deficiency.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people with a body mass index of 25-32 kg/m2 Serum vitamin D deficiency (less than 30 ng/mL) Age over 65 years old No chronic and acute inflammatory and infectious diseases Not suffering from diabetes and thyroid diseases Not suffering from Alzheimer's and dementia Not receiving alcohol and smoking Not receiving medication or a disorder that affects vitamin D metabolism (anticonvulsant drugs, antituberculosis drugs, glucocorticoids, HIV drugs) Not receiving vitamin D and N-acetyl cysteine and antioxidant supplements in the last three months Non-participation in other clinical trial studies at the same time as the present study
Exclusion criteria:
Hypercalcemia (more than 2.6 mmol/L) Dysparathyroidism, kidney failure and stones, and long-term treatment with bisphosphonates and corticosteroids. Consumption of less than 90% of prescribed supplements Unwillingness to cooperate during the intervention
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are placed in one of the four study groups using Starified Blocked Randomization (blocks of 4) based on gender and serum vitamin D level (less than 10 ng, 10-20 and 20-30). Since the amount of vitamin D and the gender of people can have a significant impact on the results of the study, to ensure the same distribution of these variables in the groups, random allocation in the form of stratified randomization and using the random block method (permuted block randomization) with quadruple and double blocks will be used. According to the sample size of 100 that has been determined. The block of four and the block of two will be produced using the online site (www.sealedenvelope.com). To apply concealment in the randomization process, unique codes will be used on medicine cans, the software will generate the desired code. As each person enters the study based on the generated sequence, the medicine package in which the desired code is recorded will be allocated to the person. Therefore, before choosing the person, no one will be aware of the type of treatment he will receive. Also, The random sequence generated during the study will be unpredictable.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. Due to the double-blindness of the study, before the start of the study, the sets of cans containing capsules will be prepared by someone other than the researcher. Also, vitamin D and N-acetyl cysteine capsules will be similar in appearance so the researcher does not know the type of capsules each group receives. In addition, the researcher will be unaware of the allocation of the participants in each of the groups until after the end of the intervention period.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Floor 6, Block 2, Shahid Beheshti University of Medical Sciences, Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-08-07, 1402/05/16
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1402.033

Health conditions studied

1

Description of health condition studied
Vitamin D deficiency
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in p21 gene expression
Timepoint
Before and after intervention
Method of measurement
Quantitative Real-time Polymerase chain reaction

2

Description
Changes in p16 gene expression
Timepoint
Before and after intervention
Method of measurement
Quantitative Real-time Polymerase chain reaction

3

Description
Changes in TNFα gene expression
Timepoint
Before and after intervention
Method of measurement
Quantitative Real-time Polymerase chain reaction

4

Description
Changes in IL-6 gene expression
Timepoint
Before and after intervention
Method of measurement
Quantitative Real-time Polymerase chain reaction

5

Description
Changes in beta-galactosidase activity
Timepoint
Before and after intervention
Method of measurement
x-gal staining

6

Description
serum IL-6
Timepoint
Before and after intervention
Method of measurement
ELISA KIT

7

Description
Serum TNFα
Timepoint
Before and after intervention
Method of measurement
ELISA KIT

Secondary outcomes

1

Description
NLR: Neutrophil to Lymphocyte Ratio
Timepoint
Before and after intervention
Method of measurement
Calculation based on complete blood count with Differential test

2

Description
C-Reactive Protein
Timepoint
Before and after intervention
Method of measurement
Elisa kit

Intervention groups

1

Description
First intervention group: 600 mg of N-acetyl cysteine +1000 units of vitamin D ​​daily for 8 weeks.
Category
Treatment - Other

2

Description
Second intervention group: 5000 units of vitamin D daily for 8 weeks
Category
Treatment - Other

3

Description
Third intervention group: 600 mg of N-acetyl cysteine +5000 units of vitamin D ​​daily for 8 weeks.
Category
Treatment - Other

4

Description
Control group: 1000 units of vitamin D daily for 8 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid modarres hospital
Full name of responsible person
Samira Rastgoo
Street address
Saadat abad ave., Yadgar Imam highway
City
Tehran
Province
Tehran
Postal code
1998967953
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
nutrition@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samira Rastgoo
Position
Phd Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2293 0824
Email
samiraa.rastgoo@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samira Rastgoo
Position
Phd Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2293 0824
Email
samiraa.rastgoo@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samira Rastgoo
Position
Phd Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2293 0824
Email
samiraa.rastgoo@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
Access starts immediately after the publication of the results
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
The data will be made available to other researchers upon reasonable request
From where data/document is obtainable
If the results and the article are published, send an email to the corresponding author.
What processes are involved for a request to access data/document
If the results and the article are published, send an email to the corresponding author.
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