comparison of lipid profiles between zinc supplementation , vitamin D supplementation, zinc and vitamin D supplementation and placebo groups before and after intervention
Design
Two arms parallel group randomized trial with blinded postoperative care
Settings and conduct
This double-blind, randomized, placebo-controlled clinical trial study was conducted in 140 obese patients referring to Imam Khomeini Hospital Endocrine Research Center.All assessments were made at baseline and after 12 weeks of intervention.Randomization assignment as blinding was done using computer-generated random numbers by a trained statistical staff.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 to 60 years old; BMI
greater than 27; willing to participate; weight stable in 3
last months. Exclusion criteria: having a history of
coronary artery disease; acute or chronic renal failure;
acute or chronic hepatic failure; presence of any chronic
2 inflammatory and autoimmune disease; and any known
malignancy; hormone therapy; other non-pathological
exclusion criteria included pregnancy; breast feeding;
post-menopause; smoking, professional athlete;
uncontrolled thyroid disorder; use of medications for
dyslipidemia or hypertension; having a special diet for
any reason prescribed by the clinic dietitian;
consumption of nutritional supplements within the past
12 weeks.
Intervention groups
Intervention groups consume: (1) 2,000 U/day vitamin D
+ zinc placebo or (2) 30 mg/day zinc + vitamin D
placebo or (3) 2,000 U/day vitamin D + 30 mg/day zinc
every day for 12 weeks.
In the control group daily, 1 zinc placebo (containing starch) and 1 placebo of vitamin D (containing starch) will be taken for 12 weeks
Main outcome variables
Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180910040997N1
Registration date:2019-04-20, 1398/01/31
Registration timing:retrospective
Last update:2019-04-20, 1398/01/31
Update count:0
Registration date
2019-04-20, 1398/01/31
Registrant information
Name
Somayeh Yosaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 2248 0864
Email address
s.yosaee@larums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-02, 1397/08/11
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Zinc, vitamin D supplementation and co-supplementation of them versus placebo on lipid profile in overweight and obese subjects
Public title
The effects of Zinc, vitamin D supplementation and co-supplementation of them versus placebo on lipid profile in overweight and obese subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 to 60 years old
BMI greater than 27
willing to participate
weight stable in 3 last months
Exclusion criteria:
having a history of coronary artery disease; acute or chronic renal failure;acute or chronic hepatic failure; presence of any chronic inflammatory and autoimmune disease; and any known malignancy
use of vitamin and mineral supplement in 3 last months
smoking
Use of any type of drug including anti-inflammatory drugs (NSAIDs, salicylates, steroids), aminoglycoside antibiotics, blood pressure control drugs and blood glucose
professional athlete
having a special diet for any reason prescribed by the clinic dietitian
A person's desire to have a weight loss diet
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation method: block randomization with block size 8
Random allocation unit: individual
Random allocation approaches: Random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
All subjects and participants in the research will be blind to the process of allocation of treatment and treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Larestan school of medical science
Street address
Deputy of research, Larestanschool of medical sciences, New city,Dadman Highway, larestan, Iran
City
Larestan
Province
Fars
Postal code
7476154538
Approval date
2018-10-01, 1397/07/09
Ethics committee reference number
IR.LARUMS.REC.1397.007
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Serum level of lipid profile including Triglyceride, HDL, LDL, TC
Timepoint
Before and 12 weeks after intervention
Method of measurement
Serum concentration of lipid profile (TG, TC, LDL, HDL)
Secondary outcomes
empty
Intervention groups
1
Description
(1) 2,000 U/day vitamin D+ zinc placebo
Category
Treatment - Drugs
2
Description
30 mg/day zinc + vitamin D placebo
Category
N/A
3
Description
2,000 U/day vitamin D + 30 mg/day zinc
Category
N/A
4
Description
Zinc placebo + vitamin D placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Endocrine Research Center
Full name of responsible person
Somayeh Yousaee
Street address
Deputy of Research, Larestanschool of Medical Sciences, New City,Dadman Highway, Larestan, Iran
City
Larestan
Province
Fars
Postal code
7476154538
Phone
+98 71 5234 2877
Email
s_yousai2006@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Zahra Keshtkaran
Street address
Deputy of Research, Larestan School of Medical sciences, New city,Dadman Highway, Larestan, Iran
City
Larestan
Province
Fars
Postal code
07152342877
Phone
+98 71 5234 2877
Email
s.yosaee@larums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Somaye Yosaee
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of research, Larestanschool of medical sciences, New city,Dadman Highway, Larestan, Iran
City
Larestan
Province
Fars
Postal code
07152342877
Phone
+98 71 5234 2877
Email
s_yousai2006@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Somaye Yosaee
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of research, Larestan school of medical sciences, New city,Dadman Highway, Larestan, Iran
City
Larestan
Province
Fars
Postal code
07152342877
Phone
+98 71 5234 2877
Email
s_yousai2006@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Somaye Yosaee
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of research, Larestanschool of medical sciences, New city,Dadman Highway, Larestan, Iran
City
Larestan
Province
Fars
Postal code
07152342877
Phone
+98 71 5234 2877
Email
s_yousai2006@yahoo.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available