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Comparing the Efficacy of Nano Calcium and Marketed Calcium Supplements in Improving Bone Health in Osteopenia Population : A Randomized Clinical Trial

Protocol summary

Summary
Current study will compare the effectiveness of AceNano Calcium and Carbonate Calcium in improving Improving Bone Health in Osteopenia Population. The purpose of this supplement to prevent osteoporosis in people with osteoporosis and T-score between minus one and minus two and a half more.This study is a interventional, phase III, randomized, two- arm parallel group. In this clinical trial, 40 osteopenic participate which are divided into two groups:1- 20 people AceNano Calcium usage and 2-20 use Carbonate Calcium as a calcium supplementation. Inclusion criteria: diagnosis of osteopenia based on BMD results the T-Score between -1 and -2.5, both genders, aged between 45 and 70 years. Exclusion Criteria: any disorder that impairs mental and relationship disorders questionnaire or other words that researchers can study verbal communication to interact with the person, pregnant or nursing women, a disease affecting bone mineral density ( acute or chronic renal failure, liver failure, any type of cancer, chronic diarrhea ( more than two weeks ). Current study will measure blood Calcium bone, marker turnover, Osteocalcin and bone alkaline phosphatase blood.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201401131414N31
Registration date: 2014-02-22, 1392/12/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-22, 1392/12/03
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neutrino Noavarane Nano
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparing the Efficacy of Nano Calcium and Marketed Calcium Supplements in Improving Bone Health in Osteopenia Population : A Randomized Clinical Trial
Public title
The efficacy of Nano calcium in improving bone health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion: Osteopenia with T-Score -1 and -2.5; both male and female; Age between 45 to 70 Exclusion: Presence of any systemic or chronic illness such as: Chronic hepatic diseases, Clinically complicated pulmonary, cardiac, hematologic, gastrointestinal, Serious psychological problems such as severe anxiety or depression, Any diagnosed malignancy, A history of active inflammatory illness, Breast feeding, pregnancy or intention to become pregnant during the study period (female patients), Any drug hypersensitivity, Radiotherapy, Chemotherapy or any immunosuppressive drug use, Use of another investigational agent within 6 months of the screening visit, History of kidney stone, hyperparathyroidism or sarcoidosis.
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Endocrinology Metabolism Research Institute
Street address
5th floor, Shariati Hospital, Jalla Ale Ahmad St
City
Tehran
Postal code
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
EC-00329

Health conditions studied

1

Description of health condition studied
Osteopenia
ICD-10 code
M85.9
ICD-10 code description
Disorders of Bone Density and Structure, Unspecified

Primary outcomes

1

Description
Osteocalcin
Timepoint
befor and after intervention
Method of measurement
photometery

Secondary outcomes

1

Description
serum level of Vitamin D
Timepoint
before and after intervention
Method of measurement
ELISA

2

Description
PTH
Timepoint
before and after intervention
Method of measurement
ELISA

3

Description
serum Alkalinphosphatase
Timepoint
before and after intervention
Method of measurement
photometery

4

Description
Alb
Timepoint
before and after intervention
Method of measurement
photometery

5

Description
Protein
Timepoint
before and after intervention
Method of measurement
photometery

6

Description
Cr
Timepoint
before and after intervention
Method of measurement
photometery

7

Description
Calcium
Timepoint
before and after intervention
Method of measurement
photometery

8

Description
Phosphate
Timepoint
before and after intervention
Method of measurement
photometery

Intervention groups

1

Description
Marketing Carbonate Calcium with 500 mg, 2 times daily , 3-month use .
Category
Treatment - Drugs

2

Description
AceNano Calcium with 72 mg Carbonate Calcium Elemental, 3 times daily, 3-month use
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinolog and Metabolism Research Institute
Full name of responsible person
Dr. AbbasAli Keshtkar
Street address
5 th floor, Shariati Hospital,Jallale Ale Ahmad St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neutrino Noavarane Nano
Full name of responsible person
Ghorbankhani
Street address
No 20,9th Floor, Goldis Tower , 2nd Sadeghieh Sq,Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neutrino Noavarane Nano
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endocrinolog and Metabolism Research Institute
Full name of responsible person
Dr.Bagher Larijani
Position
Endocrinologist
Other areas of specialty/work
Street address
5th floor, Shariati hospital, Jallale Ale Ahmad
City
Tehran
Postal code
Phone
+98 21 8822 0053
Fax
+98 88220052
Email
emrc@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Chronic Disease Research Center
Full name of responsible person
Maryam Sanaei
Position
MSc of microbiology/ clinical trial coordinator
Other areas of specialty/work
Street address
No111,19th Allay, North Karegar, Amir Abad
City
Tehran
Postal code
Phone
+98 21 8835 4309
Fax
Email
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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