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Effect of vitamin D supplementation on the glycaemic status and body fat mass in prediabetic adults: a randomized placebo- controlled trial

Protocol summary

Summary
Objectives: to examine the effect of vitamin D supplementation on glycaemic control and percentage of body fat mass in prediabetic individuals. Design: a single blind, randomized placebo- controlled trial. Sample size was 120 prediabetic adults. Setting and conduct: the subjects using stratified block randomization according to percentage of body fat mass randomly assigned in intervention group (1000 IU/daily vitamin D) or placebo group (placebo tablet) for 3 months. Participants: Participants were adults aged 18-70 years old with prediabetes. exclusion criteria including: type 1 or type 2 diabetes, kidney diseases, sarcoidosis, cancers, hyperparathyroidism, heart diseases, liver diseases, pregnant and breastfeeding, hypercalcaemia, inflammatory bowel disease, cystic fibrosis, gastric bypass surgery, cholecystectomy, and patients who changed their lifestyle and dietary habits during the intervention period. Fasting blood glucose (FBS), Glycated hemoglobin (HbA1c), homeostasis model assessment of insulin resistance (HOMA-IR), serum 25(OH)D levels, and percentage fat mass (FM) were assessed before and after the intervention in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016090529508N3
Registration date: 2016-10-10, 1395/07/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Rasoul Zarrin
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
rasoul.zarrin@uqconnect.edu.au
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-06-13, 1394/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on the glycaemic status and body fat mass in prediabetic adults: a randomized placebo- controlled trial
Public title
Effect of vitamin D supplementation on the glycaemic status and body fat mass in prediabetic adults: a randomized placebo- controlled trial
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: prediabetic adults; vitamin D Insufficient; 30-70 age group Exclusion criteria: any diseases which may affect vitamin D metabolism and status or blood glucose control; such as type 1 or type 2 diabetes; kidney diseases; sarcoidosis; cancers; hyperparathyroidism; heart diseases; liver diseases; pregnant and lactating women; poly cystic ovarian syndrome; hypercalcemia; inflammatory bowel disease; cystic fibrosis; gastric bypass surgery; cholecystectomy; serious pulmonary diseases; patients took anti - convulsants; digoxin; contraceptives; orlistat and vitamin D supplements within the last three months; smoking and drinking alcohol; patients who changed their lifestyle and dietary habits during the intervention period; having the threshold serum 25(OH)D of either D3 < 10 nmol/ml or > 150 nmol/ml; patients without informed consent and those who were taking less than 90% of the supplements given to take during the study.
Age
From 30 years old to 70 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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Urmia University of Medical Sciences
Street address
Urmia university of Medical Sciences, Urmia
City
Urmia
Postal code
Approval date
2014-12-30, 1393/10/09
Ethics committee reference number
umsu.rec.1393.212

Health conditions studied

1

Description of health condition studied
Other disorders of intestinal carbohydrate absorption
ICD-10 code
E74.3
ICD-10 code description
Glucose-galactose malabsorption

Primary outcomes

1

Description
fasting blood sugar (FBS)
Timepoint
before intervention, 3 months after intervention
Method of measurement
mg/dl

2

Description
Glycated hemoglobin (HbA1c)
Timepoint
before intervention, 3 months after intervention
Method of measurement
%, Gama

3

Description
Serum insulin
Timepoint
before intervention, 3 months after intervention
Method of measurement
mg/dl

4

Description
Percentage body fat mass
Timepoint
before intervention, 3 months after intervention
Method of measurement
%, kaliper

5

Description
Serum 25(OH)D
Timepoint
before intervention, 3 months after intervention
Method of measurement
ng/ml

6

Description
homeostasis model assessment of insulin resistance (HOMA-IR)
Timepoint
before intervention, 3 months after intervention
Method of measurement
FBS*Insulin

Secondary outcomes

1

Description
Daily sun exposure
Timepoint
before intervention, 3 months after intervention
Method of measurement
hour

2

Description
Waist Circumference
Timepoint
before intervention, 3 months after intervention
Method of measurement
cm

3

Description
Body Mass Index (BMI)
Timepoint
before intervention, 3 months after intervention
Method of measurement
kg/m2

Intervention groups

1

Description
Control group: placebo tablet for 3 months
Category
N/A

2

Description
Intervention group: 1000 IU/daily vitamin D for 3 months
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam KHomeini hospital
Full name of responsible person
Dr. Rasoul Zarrin
Street address
Emam KHomeini hospital, Ershad Street, Modarres Ave, Urmia, Iran
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences, Jahad Street, Resalat Ave, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Dr. Rasoul Zarrin
Position
Assistant Professor of Nutrition
Other areas of specialty/work
Street address
School of Medicine,Department of Nutrition, Nazlou Pardis, Sero Ave
City
Urmia
Postal code
Phone
+98 44 3346 9935
Fax
Email
wwzarrin@yahoo.com; Rasoul.Zarrin@uqconnect.edu.au
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Rasoul Zarrin
Position
Assistant Professor of Nutrition
Other areas of specialty/work
Street address
School of Medicine, Department of Nutrition, Nazlou Pardis, Sero Ave
City
Urmia
Postal code
Phone
+98 44 3346 9935
Fax
Email
wwzarrin@yahoo.com; Rasoul.Zarrin@uqconnect.edu.au
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Farzaneh GHasemi
Position
MSc
Other areas of specialty/work
Street address
Emam KHomeini Hospital, Ershad Street, Modarres Ave, Urmia
City
Urmia
Postal code
Phone
+98 44 3345 7278
Fax
Email
farzaneh.ghassemit@gmail.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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