Protocol summary

Study aim
In this study patients will be assessed in order to determine the effects effect of vitamin D and vitamin C supplementation along with endurance physical activity on metabolic according to IDF definition.
Design
This study will be conducted as a randomized controlled trial.
Settings and conduct
Subjects were randomly divided into six groups including 30 subjects (taking vitamin D supplement, vitamin C supplement and placebo).(vitamin D, vitamin D and physical activity, vitamin C, vitamin C and physical activity and finally, placebo and placebo with physical activity) For each patient anthropometric measurements (height, weight and waist circumference) and general characteristics will be assessed at the baseline and end of the study will be filled. 24-h food record questionnaire in order to assessment of food intake and physical activity questionnaire will be complete during the trial. 10 cc fasting blood samples from each patient will be taken at the beginning and end of the intervention.
Participants/Inclusion and exclusion criteria
Participants including major eligibility criteria: Participants having MetS, according to IDF definition, age between 30 and 50 years, both male and female. and Exclusion criteria are: use medications that might affect blood pressure, plasma glucose and lipid profiles throughout the study, they were excluded. The use of any other supplements containing vitamin D and C was also being the exclusion criteria
Intervention groups
Intervention groups will receive vitamin D alone daily 1 vitamin D tablets containing 2000 IU Group two taking Vitamin D and doing physical activity - group three 1 vitamin C tablet containing 500mg with meal alone, group four; taking Vitamin C and doing physical activity. group five taking placebo alone and final group take placebo and doing physical activity daily for 12 weeks. Main outcome measures (variables): Serum cholesterol, LDL-C, HDL-C, TG, vitamin D and vitamin C, blood pressure and fasting blood glucose in both groups before and after the intervention will be measured.
Main outcome variables
Main outcome measures (variables): Serum cholesterol, LDL-C, HDL-C, TG, vitamin D and vitamin C, blood pressure and fasting blood glucose in both groups before and after the intervention will be measured.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161110030823N2
Registration date: 2018-02-01, 1396/11/12
Registration timing: retrospective

Last update: 2018-02-01, 1396/11/12
Update count: 0
Registration date
2018-02-01, 1396/11/12
Registrant information
Name
Halgord Farag
Name of organization / entity
Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
halgordtamas@gmail.com
Recruitment status
Recruitment complete
Funding source
00
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2016-05-01, 1395/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation vitamin D and vitamin C analoge with endurance physical activity on metabolic syndrome patients
Public title
The effect of vitamin D and vitamin C given with outdoor physical activity on obesity, Blood sugar, blood pressure, body cholesterol
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants having MetS, according to IDF definition waist circumference ≥ 94 cm for men and ≥ 80 cm for women (triglyceride level ≥ 150 mg/dl), (high density lipoprotein < 40 mg/dl in male and < 50 mg/dl in female), (raised systolic blood pressure ≥130 or diastolic blood pressure ≥ 85 mm Hg), (raised fasting plasma glucose ≥100 mg/dl), age between 30 and 50 years, both male and female, living in Halabja at least 3 years.
Exclusion criteria:
If the study participants use medications that might affect blood pressure, plasma glucose and lipid profiles throughout the study, they were excluded. The use of any other supplements containing vitamin D and C was also being the exclusion criteria. Getting pregnant at the middle of the study and lack of use the supplements for average 10 days, was excluded. For physical activity, if the participants are not follow to recommended time and less than 25 mints, they were being excluded. Individuals with type I and type II diabetes who are taking oral hypoglycemic agents or injecting insulin, or any medical therapy affecting the result, smoker [Light smokers include low-rate daily smokers (< 5 cigarettes per day during their life)], heart failure and those with known chronic renal insufficiency or creatinine ≥1.4 mg/dl; inflammatory gastrointestinal pathology or malabsorption syndrome, neoplasms, alcohol intake >40 g/day; and long-term institutionalization or residing in nursing homes, pregnancy or lactation as well as post-menopausal women and women with surgical menopause was not to be included. Patients with a history of bariatric surgery and use of weight-loss medications was also not be included. those with high triglyceride level > 400 mg/dl, higher systolic blood pressure level >140 and diastolic blood pressure > 90, and finally raised fasting plasma glucose >125 mg/dl was not included.
Age
From 30 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 180
Actual sample size reached: 21
Randomization (investigator's opinion)
Randomized
Randomization description
individuals will be in terms of age and gender variables, first blocks of individuals and individuals in each block are completely randomized to the study population.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study blindness method will be used to allocate a training expert to individuals, and the supplement or placebo will be given to him by the subjects he or she will study. Therefore, the study researchers, as well as the subjects studied, will not be informed of the number of subjects
Placebo
Used
Assignment
Parallel
Other design features
The randomization method in this study will be done using the random numbers table. Thus, the matching of individuals will be in terms of age and gender variables, first blocks of individuals and individuals in each block are completely randomized to the study population. The study blindness method will be used to allocate a training expert to individuals, and the supplement or placebo will be given to him by the subjects he or she will study. Therefore, the study researchers, as well as the subjects studied, will not be informed of the number of subjects

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz blv., Ghods st. Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Province
Tehran
Postal code
1416643931
Approval date
2016-02-16, 1394/11/27
Ethics committee reference number
IR.TUMS.REC.1395.2832

Health conditions studied

1

Description of health condition studied
metabolic syndrome
ICD-10 code
E78.8
ICD-10 code description
lipoprotein metabolic disorder

Primary outcomes

1

Description
serum level of vitamin D
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
ng/ml - specific kits

2

Description
serum level of vitamin C
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
HPLC - mg/dL.

3

Description
systolic blood pressure
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Mercury Sphygmomanometerwith the accuracy of 1 mmgh

4

Description
diastolic blood pressure
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Mercury Sphygmomanometerwith the accuracy of 1 mmgh

5

Description
high-density Lipoprotein
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
mg/dL - was measured after precipitation of the apolipoprotein B containing lipoproteins with phosphotungistic acid

6

Description
low-density lipoprotein
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
mg/dL - enzymatic – photometric

7

Description
Triglyceride
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
mg/dL -using triglyceride kits by enzymatic colorimetric tests with glycerol phosphate oxidase

8

Description
Fasting plasma glucose
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
enzymatic colorimetric method using glucose oxidase

Secondary outcomes

1

Description
Body mass index
Timepoint
before treatment and 3 months following end of treatment
Method of measurement
weight / (height)2 - kg/m2

2

Description
waist circumference
Timepoint
before treatment and 3 months following end of treatment
Method of measurement
cm – tapeline

3

Description
parathyroid hormone
Timepoint
before treatment and 3 months following end of treatment
Method of measurement
Elisa

4

Description
calcium
Timepoint
before treatment and 3 months following end of treatment
Method of measurement
chemical analyzers instrument

Intervention groups

1

Description
Vitamin C group: who was take only 500 mg/day vitamin C supplements [Morning Time]
Category
Treatment - Drugs

2

Description
Vitamin C plus physical activity group either morning 7:30 A.M and afternoon after 3:00 PM: who was participated in 30 min/d of endurance physical activity and also will take 500 mg/d vitamin C supplements
Category
Treatment - Drugs

3

Description
Vitamin D group: who was take only 2000 IU/day vitamin D supplements (Morning Time)
Category
Treatment - Drugs

4

Description
Vitamin D plus physical activity group either morning 7:30 PM and afternoon after 3:00 PM: who was participated in 30 min/d of endurance physical activity and also was taken 2000 IU/day vitamin D supplements
Category
Treatment - Drugs

5

Description
Placebo group: A- who were participate in 30 min/d of endurance physical activity and also will take placebo. B- Who were not participated in 30 min/d of endurance physical activity and also was taken placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Halabja Hospital
Full name of responsible person
Salar Hussen
Street address
Mamostayan blv., Sharavani st., Halabja Hospital Center for control of communicable and non-communicable - Iraq
City
Halabja
Postal code
1234
Phone
+964 53 885 2997
Fax
Email
salar.husin@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms Salehi Rad
Street address
Vice chacellor for research , Tehran University of Medical Sciences ,Poorsina str, Tehran
City
Tehran
Province
Tehran
Postal code
00
Phone
+98 21 8891 3469
Email
b_salehirad@farabi.tums.aac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Halgord Ali M.Farag
Position
PhD Student of nutritional science
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Iraq-Slemani-halabja
City
Halabja
Province
Halabja
Postal code
1234
Phone
+98 219123717305
Fax
Email
Halgordtamas@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Hosseinzadeh MD
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics—Tehran University of Medical Sciences – No44- Hojjat-dost Alley- Naderi St. Keshawarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 219123717305
Fax
Email
mhosseinzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Halgord Ali M.Farag
Position
PhD Student of nutritional science
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Keshavarz blv., Ghods st. Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Province
Tehran
Postal code
141664393
Phone
+964 53 885 2997
Fax
Email
Halgordtamas@gmail.com
Web page address

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participant should have metabolic syndrome based on IDF definition age between 30-50 years both male and female residence in Halabja for long period.
When the data will become available and for how long
After 6 month after the end stage data collection it will be ready ( approximately Nov 2016)
To whom data/document is available
This only available for people working in academic institutions
Under which criteria data/document could be used
Any analysis that ethically proved by institute committee
From where data/document is obtainable
E mail address (Halgordtamas@gmail.com)
What processes are involved for a request to access data/document
All data available in Excels sheet
Comments
00
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