The effect of vitamin D and vitamin C given with outdoor physical activity on obesity, Blood sugar, blood pressure, body cholesterol

• Register: IRCT
• Last refreshed on: 26 March 2018
• Main ID: IRCT20161110030823N2
• Date of registration: 2018-02-01
• Prospective Registration: No
• Primary sponsor: Tehran University of Medical Sciences
• Public title: The effect of vitamin D and vitamin C given with outdoor physical activity on obesity, Blood sugar, blood pressure, body cholesterol
• Scientific title: The effect of supplementation vitamin D and vitamin C analoge with endurance physical activity on metabolic syndrome patients
• Date of first enrolment: 2016-03-01
• Target sample size: 180
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/24378
• Study type: observational
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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, 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 description: The study blindness method will be used to allocate a training expert to i
• Phase: 2-3

Countries of recruitment

Iraq

Contacts

• Name: Dr. Mohammad Javad Hosseinzadeh MD
• Affiliation: Tehran University of Medical Sciences

• Name: Halgord Ali M.Farag
• Affiliation: Tehran University of Medical Sciences

Key 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 minimum: 30 years
Age maximum: 50 years
Gender: Both

Health Condition(s) or Problem(s) studied

metabolic syndrome.
lipoprotein metabolic disorder

Intervention(s)

Intervention 1: Vitamin C group: who was take only 500 mg/day vitamin C supplements [Morning Time]. Intervention 2: 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. Intervention 3: Vitamin D group: who was take only 2000 IU/day vitamin D supplements (Morning Time). Intervention 4: 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. Intervention 5: 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.

Primary Outcome(s)

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.

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.

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

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.

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

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

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

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.

Secondary Outcome(s)

Calcium. Timepoint: before treatment and 3 months following end of treatment. Method of measurement: chemical analyzers instrument.

Parathyroid hormone. Timepoint: before treatment and 3 months following end of treatment. Method of measurement: Elisa.

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

Waist circumference. Timepoint: before treatment and 3 months following end of treatment. Method of measurement: cm – tapeline.

Source(s) of Monetary Support

Tehran University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Tehran University of Medical Sciences