Protocol summary

Summary
Our objective in this study is assessing the combined effect of vitamin E and C supplementation on lipid profile in elderly residents in Isfahan. This double-blind intervention study was conducted on 210 participants aged 60 -75 years old. Exclusion criteria: The lack of a liver disorder, renal failure and mal absorption, any kind of cancer, or any illness that may interfere with the absorption of antioxidants, taking medications that could seriously disrupt lipid metabolism, those who at baseline diagnosed hyperlipidemic of course with The experiment was done, and Did not receive a medication to control it and required medication. They were divided into intervention and control groups based on sex and age. Intervention group take vitamin E (300 mg/day) and vitamin C (400 mg/day) and the control group take placebo for one year. At baseline of study, background information was collected through general questionnaire and dietary intake was collected through three-day food records every two months. Before intervention, after 6 months and at the end of the study triglyceride, total cholesterol, and high density lipoprotein and low density lipoprotein were measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052517831N1
Registration date: 2014-06-11, 1393/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-11, 1393/03/21
Registrant information
Name
Mahsa Malekahmadi
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 125 0467
Email address
m-malekahmadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
tehran university of medical sience
Expected recruitment start date
2010-01-21, 1388/11/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The combined effect of vitamins E and C supplementation on lipid profile in elderly residents in Isfahan
Public title
effect of vitamins E and C on lipid profile in elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 60 to 75 years; literacy rate higher than fifth grade; Exclusion criteria:The lack of a liver disorder, renal failure and mal absorption, any kind of cancer, or any illness that may interfere with the absorption of antioxidants; Smoking, tobacco and drug abuse; taking Vitamin C and E supplementation before entering the study; taking medications that could seriously disrupt lipid metabolism, such as fibrates, nicotinic acid, glucocorticoids; those who at baseline diagnosed hyperlipidemic of course with The experiment was done, and did not receive a medication to control it and required medication; severe disability
Age
From 28 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods street, Keshavarz square
City
Tehran
Postal code
Approval date
2013-01-08, 1391/10/19
Ethics committee reference number
2044379051

Health conditions studied

1

Description of health condition studied
Pure hypercholesterolaemia
ICD-10 code
E78.0
ICD-10 code description
Familial hypercholesterolaemiaFredrickson hyperlipoproteinaemia, type IIaHyperbetalipoproteinaemiaHyperlipidaemia, group ALow-density-lipoprotein-type [LDL] hyperlipoproteinaemia

2

Description of health condition studied
Mixed hyperlipidaemia
ICD-10 code
E78.2
ICD-10 code description
Broad- or floating-betalipoproteinaemiaFredrickson hyperlipoproteinaemia, type IIb or IIIHyperbetalipoproteinaemia with prebetalipoproteinaemiaHypercholesterolaemia with endogenous hyperglyceridaemiaHyperlipidaemia, group CTubero-eruptive xanthomaXanthoma

3

Description of health condition studied
Other hyperlipidaemia
ICD-10 code
E78.4
ICD-10 code description
Familial combined hyperlipidaemia

4

Description of health condition studied
Lipoprotein deficiency
ICD-10 code
E78.6
ICD-10 code description
AbetalipoproteinaemiaHigh-density lipoprotein deficiencyHypoalphalipoproteinaemiaHypobetalipoproteinaemia (familial)Lecithin cholesterol acyltransferase deficiencyTangier disease

5

Description of health condition studied
Hyperlipidaemia, unspecified
ICD-10 code
E78.5
ICD-10 code description

Primary outcomes

1

Description
total cholestrol
Timepoint
at baseline, after 6 mounth, after 1 year
Method of measurement
enzimatically- colorimetry

2

Description
LDL
Timepoint
at baseline, after 6 mounth, after 1 year
Method of measurement
enzimatically- colorimetry

3

Description
HDL
Timepoint
at baseline, after 6 mounth, after 1 year
Method of measurement
enzimatically- colorimetry

4

Description
TG
Timepoint
at baseline, after 6 mounth, after 1 year
Method of measurement
enzimatically- colorimetry

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group, daily received 300 mg of vitamin E (alfa-Tocopheryle Acetate) (ZAKARIYAYE RAZI manufacturer company), Which is exactly equal to 300 IU, and 400 mg of vitamin C (ascorbic acid)) OSVEH manufacturer company) for one year.
Category
Other

2

Description
control group, received 2 placebo (A product in terms of physical and chemical properties is quiet similar to C and E vitamins) for one year.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hashtbehesht laboratory
Full name of responsible person
Mahsa Malekahmadi
Street address
Hashtbehesht laboratory, eastern Hashtbehesht avenue
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Rezaei
Street address
Tehran University of Medical Sciences, Ghods street, Keshavarz square
City
Tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Mansour Alavi
Position
phd/assistant
Other areas of specialty/work
Street address
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, NO 44, Hojatdoost alley, Naderi street
City
Tehran
Postal code
Phone
+98 913 319 5920
Fax
Email
amalavi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Malekahmadi
Position
phd/assistant
Other areas of specialty/work
Street address
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, NO 44, Hojatdoost alley, Naderi street
City
Tehran
Postal code
Phone
+98 913 125 0467
Fax
Email
mahsa_malekahmadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Malekahmadi
Position
student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
mahsa_malekahmadi@yahoo.com
Web page address

Sharing plan

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