Protocol summary

Study aim
The aim of the present study was to investigate the protective effect of exercise combined with calcium and vitamin D supplementation on angiogenesis indices in elderly men.
Design
The clinical trial will be a controlled, double-blind, parallel-group trial (supplement and exercise, placebo and exercise and control) on 45 elderly people. A random number table will be used for randomization.
Settings and conduct
After selecting 45 eligible elderly men who were referred to health centers in Zabol city and grouping the individuals, for four weeks, the exercise groups will follow three exercise sessions with 5% of body weight per week, and the supplement groups will follow a program of one 1000 mg calcium tablet per day along with one 50,000 international unit vitamin D capsule per week. For double-blinding, before the start of the study, the packages containing the supplement and placebo will be marked by a person other than the researcher, and the supplement and placebo will be taken under the supervision of the same person.
Participants/Inclusion and exclusion criteria
Age range: 60-70 years, BMI between 18.5 and 25 kg/m2, having a general level of physical and mental health, inactive lifestyle. Exclusion criteria: using walking aids, using medication in the previous 6 months, having cardiovascular diseases
Intervention groups
Intervention group 1: Training with supplement, one 1000 mg calcium tablet per day along with one 50,000 IU vitamin D capsule per week and squat exercises 3 sessions per week. Intervention group 2: Training with placebo, one 1000 mg placebo tablet per day along with one placebo capsule per week and squat exercises. Control group: Continuing daily activities without intervention
Main outcome variables
Vascular endothelial growth factor, Nitric oxide, Fibroblast growth factor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220322054338N3
Registration date: 2025-03-29, 1404/01/09
Registration timing: prospective

Last update: 2025-03-29, 1404/01/09
Update count: 0
Registration date
2025-03-29, 1404/01/09
Registrant information
Name
elham ghasemi
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3123 2080
Email address
elhamghasemi@uoz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-04, 1404/01/15
Expected recruitment end date
2025-05-05, 1404/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a course of vitamin D and calcium supplementation along with squat exercises on angiogenesis indices in the elderly
Public title
The effect of vitamin D and calcium supplementation and squat exercises on angiogenesis indices in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range is 60-70 years BMI between 18.5- 25 kg/m2 Inactive lifestyle Having general physical and mental health
Exclusion criteria:
Inability to walk Using the drug Having chronic diseases, especially cardiovascular diseases
Age
From 60 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of numbers is done using Random Allocation software and permutation block method. People will be assigned to three groups using ternary permutation blocks. To do this, the letters A, B, and C will be considered for the two intervention and control groups, respectively. The possible states in the ternary block are six states including CAB, BCA, CBA, ACB, BAC, ABC. Each state will be written on a card. The cards will be assigned numbers one to six. Then, one of the six possible states will be selected using dice and based on that, the selected patients will be assigned to three groups. This process will continue until the sample size is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the supplement group will receive 1,000 mg of calcium daily and 50,000 IU of vitamin D weekly. The placebo groups will receive the same number of starch tablets and capsules. Before the study begins, the supplement and placebo packages will be marked by someone other than the researcher so that the researcher and participants are unaware of the type of capsules they are receiving. The supplement and placebo will be administered under the supervision of the same person.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Committee of Ethics in Research of University of Sistan and Baluchistan
Street address
University blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Approval date
2024-11-09, 1403/08/19
Ethics committee reference number
IR.USB.REC.1403.044

Health conditions studied

1

Description of health condition studied
Elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fibroblast growth factor
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA

2

Description
Nitric Oxide
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA

3

Description
Vascular endothelial growth factor
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
Body Mass Index
Timepoint
Beginning and end of the intervention
Method of measurement
Inbody70 body composition analyzer

Intervention groups

1

Description
Intervention group: 4 weeks of training with supplements, one 1000 mg calcium tablet per day along with one 50000 international units of vitamin D capsule per week and squat exercises 3 sessions a week.
Category
Treatment - Other

2

Description
Intervention group: 4 weeks of placebo training, one 1000 mg placebo tablet (containing lactose and edible paraffin) per day, along with one 50,000 IU placebo capsule (corn starch and Avicel) per week, and resistance squat training 3 sessions per week.
Category
Placebo

3

Description
Control group: Tracking activities and daily regimen without any interference
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Zabol city
Full name of responsible person
Elham Ghasemi
Street address
Kilometer two of Bonjar road
City
zabol
Province
Sistan-va-Balouchestan
Postal code
98613-35856
Phone
+98 54 3123 2082
Email
elhamghasemi@uoz.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President for Research, University of Sistan and Baluchestan
Full name of responsible person
Dr. Nour mohammad Yaqhoubi
Street address
Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6766
Email
yagoubi@mgmt.usb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President for Research, University of Sistan and Baluchestan
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
University of Zabol
Full name of responsible person
Elham Ghasemi
Position
Assistant Professor of department of Sport Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Kilometer two of Bonjar road
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861335856
Phone
+98 56 3242 4947
Email
elhamghasemi@uoz.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Dr. Shila Nayebifar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6766
Email
shila_nayebifar@ped.usb.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Zabol
Full name of responsible person
Elham Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Kilometer two of Bonjar road
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861335856
Phone
+98 56 3242 4947
Email
elhamghasemi@uoz.ac.ir

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
Participants' information will be made available to other researchers after being de-identified
When the data will become available and for how long
After the publication of the final research report.
To whom data/document is available
Researchers
Under which criteria data/document could be used
Citing the findings by citing the source
From where data/document is obtainable
Those interested in more information can contact through the email and address below: Mailing address: University of Zabol Email: elhamghasemi@uoz.ac.ir
What processes are involved for a request to access data/document
Those interested in more information can contact through the email and address below: Mailing address: University of Zabol Email: elhamghasemi@uoz.ac.ir
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