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The Effect of Vitamin D Supplementation on Metabolic Syndrome Indicators among Food In-secured, Vitamin D Deficient ; A Randomised Clinical Trial

Protocol summary

Summary
General objective: To assess the effect of vitamin D supplementation on metabolic syndrome among older adults in Karaj city, Alborz province in Iran. A two-arm randomised controlled trial (RCT) will be conducted by recruiting participants. Inclusion Criteria: Food insecure, metabolic syndrome; Vitamin D deficiency Exclusion Criteria: those who are already taking any type of vitamin D supplements, Individuals with a history of allergy, Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc., Intervention group: The intervention will start from 21 of April 2017 to 22 of June 2017 for 2 months. The intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks plus pamphlets and brochures about nutrition and health at the beginning of the study. Control group: The respondents in control group will receive placebo plus brochures and pamphlets related to nutrition and health at the beginning of the study. The data collection process will identify the older adults for both groups; intervention and control. Consent will be obtained from those who are eligible. Anthropometric measurement (height, weight, body mass index, and waist circumference), blood pressure measurement, blood taking and three-day food record will be obtained during baseline from all study respondents in the intervention and control groups. Primary Output: Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l. Secondary Output: Reduction anthropometry (body mass index (BMI) and waist circumference (WC), Improved Biomarkers indicators (lipid profile, fasting blood fast), improved blood pressure before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121831449N1
Registration date: 2017-05-08, 1396/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Maryam Zarei
Name of organization / entity
Ministry of Health and Medical Education
Country
Iran (Islamic Republic of)
Phone
+98 21 8145 4979
Email address
zarei@health.gov.ir
Recruitment status
Recruitment complete
Funding source
Ministry of Health, Nutrition Department.
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The Effect of Vitamin D Supplementation on Metabolic Syndrome Indicators among Food In-secured, Vitamin D Deficient ; A Randomised Clinical Trial
Public title
Effect of vitamin D supplementation on metabolic syndrome in elderlies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Food insecure, waist Circumference>90 cm, body mass index ≥30 kg/m2, fasting blood sugar>100 mg/dl, high blood pressure (systolic >135 mmHg and diastolic >85 mmHg) and dyslipidaemia (Low density lipoprotein≥ 240 mg/dl, high density lipoprotein<40 mg/dl, total cholesterol≥ 160 mg/dl, triglyceride ≥ 200 mg/dl), serum 25(OH) D level <30 ng/ml, no use of vitamin D supplementation before 60 days. Exclusion criteria: An inability or unwillingness to participate, those who are already taking any type of vitamin D supplements, Individuals with a history of allergy, those subjects with serious medical condition such as cancer, heart attack, stroke, and etc., illness that required corticosteroids or insulin, drugs are known to influence vitamin D level, steroids, anti-acids, oestrogen, people with conditions that contradict vitamin D supplementation, for example, a history of hypocalcaemia, hepatic disease or renal stones, sarcoidosis, or malignancy.
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Simple allocation randomisation will be accomplished with no stratification using a restricted (10 blocks) random number to ensure equivalence of numbers in each group using www.graphpad.com/quickcalcs/randomn2.cfm. Simple allocation randomization will be accomplished with no stratification using a restricted (10 blocks) random number to ensure equivalence of numbers in each group using www.graphpad.com/quickcalcs/randomn2.cfm. From 120 respondents (60 respondents for each group), the odd numbers will be allocated to group intervention and the even numbers to group control. In every 10 number blocks from the random table, the sequence will be checked to ensure the even numbers are equal to the odd numbers. Each number in the random table will be given a study number and assigned into one of the study groups. A table for the allocation of the participants in the study will be composed and kept in a sealed envelope. Numbered, identical, opaque sealed envelopes will be used for respondents’ allocation. The allocation envelope contains the treatment allocation identification showing either group 1 or group 2.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Research deputy Alborz Medical university
Street address
Taleghani Boulevard
City
Karaj
Postal code
Approval date
2017-02-13, 1395/11/25
Ethics committee reference number
ABZUMS.REC.1395.114

Health conditions studied

1

Description of health condition studied
Metabolic syndrome (diabetes, obesity, blood pressure and hyperlipidemia)
ICD-10 code
E10, E11,
ICD-10 code description
Metabolic disorders and nutritional

Primary outcomes

1

Description
25(OH)D
Timepoint
8 weeks
Method of measurement
blood taking (before intervention and after intervention, 2 months later)

Secondary outcomes

1

Description
Fasting Blood Pressure (FBS)
Timepoint
8 weeks
Method of measurement
blood taking before and after intervention (2months)

2

Description
Antropometrics indicators
Timepoint
8 weeks
Method of measurement
measuring height and weight before and after intervention (2months)

3

Description
Blood Pressure
Timepoint
8 weeks
Method of measurement
measure before and after intervention (2months)

4

Description
Hyperlipidemia
Timepoint
8 weeks
Method of measurement
blood taking before and after intervention (2months)

Intervention groups

1

Description
Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health.
Category
Treatment - Drugs

2

Description
Control group: The respondents in control group will receive placebo per week for 8 weeks. Plus brochures and pamphlets related to nutrition and health at the beginning of the study.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj health centres, Alborz Medical university
Full name of responsible person
DR. Mostafa Qorbani
Street address
Taleghani Boulevard
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ministry of Health, Nutrition Deprtment
Full name of responsible person
Zahra Abdollahi
Street address
Block A, Floor 10, East Ivanak, Farahzadi Boulevard, Sanat Square.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Health, Nutrition Deprtment
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
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Person responsible for general inquiries

Contact
Name of organization / entity
Alborz Medical university
Full name of responsible person
Mostafa Qorbani
Position
PhD,Assistant Professor
Other areas of specialty/work
Street address
Taleghani Boulevard.
City
Karaj
Postal code
Phone
+98 912 585 5021
Fax
Email
mqorbani1379@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ministry of Health and Medical Education , Nutrition Department
Full name of responsible person
Maryam Zarei
Position
Master of nutrition, Phd student
Other areas of specialty/work
Street address
Block A, Floor 10, East Ivanak, Farahzadi Boulevard,
City
Tehran
Postal code
Phone
+98 21 8145 4979
Fax
Email
maryam.zarei@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition Officer,Nutrition Department, Ministry of Health and Medical Education
Full name of responsible person
Maryam Zarei
Position
PhD candidate
Other areas of specialty/work
Street address
Block A, Floor 10, East Ivanak , Farahzadi Bolvare.,
City
Tehran
Postal code
Phone
+98 21 8145 4979
Fax
Email
maryam.zarei@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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