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Comparison of the Effects of Calcium, Vitamin D, and Calcium plus Vitamin D On Anthropometric Indices, Body Composition, Lipid Profile, Blood Pressure, and Blood Glucose in Overweight or Obese Premenopausal women.

Protocol summary

Summary
We aim to compare the Effects of calcium, vitamin D, and calcium plus vitamin D, as adjuvants to 500 kcal/day energy reduction, on anthropometric indices, body composition, lipid profile, blood glucose, and blood pressure in overweight or obese premenopausal women in a single-center, randomized, double-blind, placebo-controlled, multi-arm, parallel group trial. A total of 100 premenopausal overweight or obese women aged 20-50 will be assigned in a 1:1:1:1 fashion to 4 groups, using blocked randomization. The treatment groups will take 2 tablet of calcium (each containing 500 mg calcium carbonate) or vitamin D (each containing 200 IU vitamin D) alone or 2 tablet of calcium plus vitamin D (each containing 500 mg calcium carbonate and 200 IU vitamin D) and the control group will take 2 tablet of placebo per day for 8 weeks. All groups will be advised not to change their physical activity during the study. Primary outcomes (body mass index, waist circumference, body fat mass, lipid profile, blood glucose, and blood pressure) will be evaluated at baseline and endpoint of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014021116555N1
Registration date: 2014-05-18, 1393/02/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Hamide Rajaie
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
rajaieh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-05-15, 1393/02/25
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Calcium, Vitamin D, and Calcium plus Vitamin D On Anthropometric Indices, Body Composition, Lipid Profile, Blood Pressure, and Blood Glucose in Overweight or Obese Premenopausal women.
Public title
Comparison of the Effects of Calcium, Vitamin D, and Calcium plus Vitamin D On Anthropometric Indices, Body Composition, Lipid Profile, Blood Pressure, and Blood Glucose in Overweight or Obese Premenopausal women.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: premenopausal women; age between 20-50 years; BMI between 25-40 kg/m2; not having any cancer or severe endocrine, mental, hepatic, renal, gastrointestinal, cardiovascular, neurologic, rheumatologic, hematologic, skeletal, and eating disorders; not taking any medication, nutritional supplements, or herbal preparations that could affect calcium and vitamin D status, anthropometric indices, body composition, lipid profile, blood pressure, and blood glucose during the last 12 weeks; not having any history of drug intolerance or adverse reaction to the study supplements; Dairy product consumption of ≤3 serving /d; consumption of ≤5 cups of coffee/d; not being pregnant or lactating; not being a smoker or taking alcohol; not being a participant in other trials over the last 6 months; Stable body weight (body weight change˂3 kg for 3mo before intervention); providing written informed consent. exclusion criteria: development of serious adverse events during the study period and lack of adherence to the study protocol.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz, Zand Street, Olumpezeshki Department, The 7th Floor
City
shiraz
Postal code
Approval date
2013-12-29, 1392/10/08
Ethics committee reference number
92-6836

Health conditions studied

1

Description of health condition studied
overweight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Waist circumference
Timepoint
At the beginning and at the end of the intervention
Method of measurement
Tape measure

2

Description
body mass index
Timepoint
At the beginning and at the end of the study
Method of measurement
BMI will be calculated as weight (kg)/ height (m)2

3

Description
Body fat mass
Timepoint
At the beginning and at the end of the intervention
Method of measurement
Bioelectric impedance analyzer

4

Description
lipid profile
Timepoint
At the beginning and at the end of the intervention
Method of measurement
By use of bt 1500 set and pars test kit

5

Description
Blood pressure
Timepoint
At the beginnig and at the end f the intervention
Method of measurement
mmHg-piezometer

6

Description
blood glucose
Timepoint
At the beginnig and at the end f the study
Method of measurement
by Autoanalyzer method using Pars test kit

Secondary outcomes

empty

Intervention groups

1

Description
2 tablet of placebo with low calorie diet
Category
Placebo

2

Description
2 tablet of calcium (500 mg calcium carbonate /tablet) with low calorie diet
Category
Treatment - Drugs

3

Description
2 tablet of calcium plus vitamin D (500 mg calcium carbonate and 200 IU vitamin D / tablet) with low calorie diet
Category
Treatment - Drugs

4

Description
2 tablet of vitamin D (200 IU vitamin D / tablet) with low calorie diet
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emem Reza Clinic
Full name of responsible person
Hamide Rajaie
Street address
Shiraz, Namazi square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Zand Street, Olumpezeshki Department, The 7th Floor
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
School of Nutrition and Food Sciences
Full name of responsible person
Hamide Rajaie
Position
MSc candidate of Nutrition
Other areas of specialty/work
Street address
Razi blvd, in front of Bargh stadium
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
hamiderajaie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamide Rajaie
Position
MSc candidate of nutrition
Other areas of specialty/work
Street address
Razi blvd, in front of Bargh stadium, School of Nutrition and Food sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
hamiderajaie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nutrition and Food Sciences
Full name of responsible person
Hamide Rajaie
Position
MSc candidate of nutrition
Other areas of specialty/work
Street address
Razi blvd, in front of Bargh stadium
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

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