Effect of vitamin D supplementation on anthropometric indices and lipid profile among overweight and obese women : A Placebo-controlled Randomized Clinical trial
This randomized, double blind, placebo- controlled clinical trial study will be carried out to determine the effect of vitamin D supplementation on anthropometric indices and lipid profiles among women aged 18-70 with BMI>25. Seventy-six persons will be randomly assigned in two groups: Intervention group ( receive 2000 IU vitamin D/d) and control group ( receive placebo) that will be surveyed for 3 months.The patients and the medical personnel are not aware of the type of capsules in the boxes (Vitamin D or placebo). Only the researcher is aware of the code written on the boxes of the capsules; so, this study is a double-blind clinical trial.
Anthropometric indices including height ( only initially), weight, waist circumference, hip circumference, and lipid profiles, serum calcium and phosphorus, 25-OHD3, and parathyroid hormone will be measured initially and at the end of study. BMI and W/H ratio will be calculated.Energy and Nutrients intake will be assessed by using of a food dietary 24-recall questionnaire for 3 days and N4 software. Data will be analyzed using suitable statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072814195N1
Registration date:2013-09-05, 1392/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-05, 1392/06/14
Registrant information
Name
Ebrahim Falahi
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0155
Email address
falahi.e@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research and technology of Lorestan University Of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on anthropometric indices and lipid profile among overweight and obese women : A Placebo-controlled Randomized Clinical trial
Public title
Vitamin D supplementation and obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18-70 and BMI>25
Exclusion criteria: to have history of vitamin D deficiency,diabetes mellitus,thyroid disorders, hyperlipidemia,cardiac diseases and use of vitamins and mineral supplements.
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
patients will be randomly assigned into case and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Vice chancellor for research and technology, Lorestan University of Medical Sciences, Kamalvand Street, Khoramabad, Lorestan, Iran
City
Khoram abad
Postal code
Approval date
2013-06-01, 1392/03/11
Ethics committee reference number
200/86338
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
2
Description of health condition studied
overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Body Mass Index (BMI)
Timepoint
before intervention and 3 months after study
Method of measurement
balance-meter
2
Description
Waist to Hip ratio (W/H)
Timepoint
before intervention and 3 months after study
Method of measurement
meter
Secondary outcomes
1
Description
Total cholesterol
Timepoint
before intervention and 3 months after study
Method of measurement
spectrophotometer
2
Description
Triglyceride
Timepoint
before intervention and 3 months after study
Method of measurement
spectrophotometer
3
Description
Low density lipoprotein ( LDL)
Timepoint
Before intervention and 3 months after study
Method of measurement
Spectrophotometer
4
Description
High density lipoprotein (HDL)
Timepoint
before intervention and 3 months after study
Method of measurement
spectrophotometer
5
Description
serum 25 hydroxyvitamin D
Timepoint
Before intervention and 3 months after study
Method of measurement
IBL company laboratory kit
6
Description
serum calcium
Timepoint
Before intervention and 3 months after study
Method of measurement
Spectrophotometer
7
Description
serum phosphorus
Timepoint
Before intervention and 3 months after study
Method of measurement
spectrophotometer
8
Description
Parathyroid hormone (PTH)
Timepoint
Before intervention and 3 months after study
Method of measurement
ELISA
9
Description
Received energy
Timepoint
3 days during the intervention
Method of measurement
Questionnaire and N4 software
10
Description
Received calcium
Timepoint
3 days during the intervention
Method of measurement
Questionnaire and N4 software
11
Description
received phosphorus
Timepoint
3 days during the intervention
Method of measurement
Questionnaire and N4 software
12
Description
Received vitamin D
Timepoint
3 days during the intervention
Method of measurement
Questionnaire and N4 software
13
Description
Received nutrient elements
Timepoint
3 days during the intervention
Method of measurement
Questionnaire and N4 software
Intervention groups
1
Description
Patients in the control group receive oral placebo which are specifically designed to have no real effect. They are made of lactose.These pearls in terms of size, shape, packaging and name are exactly similar to the vitamin D pearls. Only the code written on the boxes are different from each other. Frequency and duration of using placebo pearls in the control group are absolutely the same as vitamin D pearls in the intervention group. One pearl will be given to the patients every 25 days until 4 doses. The pearls will be prepared from Daana Pharma Company.
Category
Treatment - Drugs
2
Description
Oral vitamin D supplement ( pearl ) 2000 IU/ d ( = 50 μg/d as cholecalciferol ) will be given to the intervention group until 3 months. Each pearl contains 50000 IU vitamin D3. One pearl will be given to the patients every 25 days until 4 doses. The pearls will be prepared from Daana Pharma Company.