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Evaluation of Satisfaction and Short-term Side effect after OsteoCalVitFort Practice in population whom use Calcium Supplement

Protocol summary

Summary
Nutritional studies have shown that many people do not get enough calcium and maintain bone mass are tailored to the needs of growth and development . The presence of vitamin D for proper absorption of calcium is necessary anymore. But calcium supplementation are creating digestive disorders and other side effect . Seems to OsteoCalVit Fort because of calcium carbonate salt, due to create fewer gastrointestinal side effects in consumers. The aim of this study is to evaluate the short-term side effects and satisfaction of the consumer of OsteoCalVit Fort compared with calcium prior to any other business deals. The present study is phase 4, single- arm,after entering care. Inclusion criteria: patients aged 45 to 70 years who used calcium supplements, good health, according to a biochemical level , the willingness to sign a written informed consent to participate in this trial, which is to announce and The exclusion criteria were People biochemical tests may not be appropriate, in certain diseases such as cancer, kidney stones or have any drug allergy, people who are willing to enter the study.By 2 times capsule of OsteoCalVit Fort for one month usage, the evaluation of the short-term side effects and satisfaction of the consumer in comparison with other marketing Calcium, will be considered .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312031414N30
Registration date: 2014-02-24, 1392/12/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-24, 1392/12/05
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
pharmedshayan pharmaceutical
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Satisfaction and Short-term Side effect after OsteoCalVitFort Practice in population whom use Calcium Supplement
Public title
Evaluation of Satisfaction and Short-term Side effect after OsteoCalVitFort Practice
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Age between 45 to 70 years old who received Calcium supplement; In good health, as determined by the principal investigator based on medical history and physical examination; Clinical laboratory evaluations within the reference range for the test laboratory; Ability to comprehend and willingness to sign the Informed Consent Form for this study. Exclusion criteria: Clinically complicated biochemical tests; Any diagnosed malignancy; Any drug hypersensitivity; History of kidney stone; hyperparathyroidism or sarcoidosis; unwilling to participation.
Age
From 45 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
2014-01-08, 1392/10/18
Ethics committee reference number
EC-00302

Health conditions studied

1

Description of health condition studied
side effect of Calcium vitamin D
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Side Effects
Timepoint
befor intervention and 1 month after intervention
Method of measurement
Questionnarie

Secondary outcomes

1

Description
Satisfaction
Timepoint
1 month Aftere the intervention
Method of measurement
Qusetionnarie

Intervention groups

1

Description
phase 4, single arm , one-month study, after entering care, 2 times OsteoCalVit Fort use for one month.
Category
N/A

Recruitment centers

1

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
pharmedshayan pharmaceutical
Full name of responsible person
Dr Hosein Gharib
Street address
No 18, 18th Allay, Kordestan
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
pharmedshayan pharmaceutical
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
Bagher Larijani
Position
Endocrinologist
Other areas of specialty/work
Street address
5th floor, Shariati hospital, Jallale Ale Ahmad St.
City
Tehran
Postal code
Phone
+98 21 8822 0088
Fax
+98 21 8822 0052
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
No 111, 2 Floor, 19th Allay, North Karegar,Amir Abad.
City
Tehran
Postal code
Phone
+98 21 8835 4309
Fax
Email
sanaeimaryam@yahoo.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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