The effects of Zinc, vitamin D supplementation and co-supplementation of them versus placebo on adipokines and indicators related to metabolism in over weight and obese subjects
Available literature suggests obese individuals have lower blood concentrations of vitamins D and zinc compared to non-obese individuals. Insulin-like growth factor (IGF)-system and adipokines play critical roles in regulating energy balance. There is limited information on how vitamins D and zinc affect biomarker of regulating energy hemostasis. This study was performed to assess the effects of vitamin D and zinc supplementation on the IGF-system and adipokines of obese participants. In a 2 x 2 factorial design randomised placebo controlled clinical trial, a total of 140 obese individuals aged >20 years, were recruited from the Iran University of Medical Science. Participants were randomly assigned to four groups receiving: (1) 2,000 IU/day vitamin D + zinc placebo; (2) 30 mg/day zinc + vitamin D placebo; (3) 2,000 IU/day vitamin D + 30 mg/day zinc; or (4) vitamin D placebo + zinc placebo for 12 weeks. A study technician carried out the random allocations using a random numbers table. All investigators, participants and laboratory technicians were blinded to the random assignments. All participants provided 3 days of dietary records and 3 days of physical activity records throughout the intervention. Blood samples were taken to quantify serum level adipokines and IGF and IGF binding protein 3 (IGFBP-3) at study baseline and after 12 weeks of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608082365N13
Registration date:2016-08-26, 1395/06/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-26, 1395/06/05
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2018-09-01, 1397/06/10
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 adipokines and indicators related to metabolism in over weight and obese subjects
Public title
The effects of Zinc, vitamin D supplementation and co-supplementation of them versus placebo on adipokines and indicators related to metabolism in over weight 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; 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.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Iran University of Medical of Sciences
Street address
Iran University of Medical of Sciences, Hemmat Highway, 1449614535, Tehran, Iran
City
Tehran
Postal code
74761568
Approval date
2016-07-11, 1395/04/21
Ethics committee reference number
IR.IUMS.REC 1395.9221324206
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Serum level of leptin
Timepoint
Before and 12 weeks after intervention
Method of measurement
Serum concentration of leptin with Laboratory Kit
Secondary outcomes
1
Description
Insulin-like growth factor-1
Timepoint
Before and 12 weeks after intervention
Method of measurement
Serum concentration with Laboratory Kit (Mediagnose; Germany)
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Control group: Consume 2 pill placebo of vitamin D and zinc contained maltodextrin ("Roshd" Pharmaceutical Incubation Center of Tehran University of Medical Sciences) every day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Vafa
Street address
Iran University of Medical Sciences, School of Public Health
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Iran University of Medical Sciences
Full name of responsible person
Dr Ali Javad Moosavi
Street address
Vice Chancellor of Research, Iran University of Medical Sciences, Hemat Express way, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
vafa.m@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
vafa.m@iums.ac.ir; rezavafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
vafa.m@iums.ac.ir; rezavafa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)