Determining the effect of alkaline drinking water on bone density in menopausal women with osteoporosis
Design
Clinical trial with control group, simple individual randomized, double blind, on 100 patients, for 3 months. Evaluation will be done at the first visit and 3 months later for bone densitometry.
Settings and conduct
The studied group was selected from patients referred to the clinics of Shahrekord University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Postmenopausal women who at least 12 months past after amenorrhea without association with pregnancy, breast-feeding or other hormonal disorders; prone to osreoprosis with T score of less than 2.5 in bone density measurement. Exclusion criteria: Gastrointestinal absorption disorder; patients with thyroid diseases; Kidney and liver diseases
Intervention groups
The intervention group received combined calcium and vitamin D (Ca-D3) supplement with loading dose of 400 International Unit(IU) of cholecalciferol and 500 mg calcium once daily, also they consumed 1.5 Litter/day alkaline drinking water (pH = 8.6 ± 0.3) (23) and Osteofos tablet (70 mg) once a week. Control group received Ca-D3 tablet daily and Osteofos tablet (70 mg/kg) once a week.
Main outcome variables
Bone Density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170929036477N3
Registration date:2021-03-09, 1399/12/19
Registration timing:retrospective
Last update:2021-03-09, 1399/12/19
Update count:0
Registration date
2021-03-09, 1399/12/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 36688487
Email address
siavashfazelian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-17, 1396/02/27
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2018-08-28, 1397/06/06
Trial completion date
2018-12-01, 1397/09/10
Scientific title
Evaluation of the effect of alkaline drinking water on bone density in menopausal women with osteoporosis
Public title
Effect of alkaline water on bone health
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women
Having at least 12 months of menstruation pause
and osteoporosis
Prone to osteoporesis with T score of less than 2.5 in bone density measurement
Exclusion criteria:
Pregnancy
Breastfeeding
Smoking
Drinking alcohol
Other hormonal disorders
Use hormones or drugs with negative or positive effect on bone metabolism (such as, estrogens and bisphosphates) in the past year
Involuntary participating in the study
Allergy to drugs
Certain complications such as hallucinations, confusion and numbness
Nausea, vomiting,
Restlessness
Seizure
Disorders of intestinal absorption
Thyroid, kidney or liver disorders
Age
From 30 years old to 75 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible subject be selected with convenience sampling and be randomly assigned into 2 groups of 50 subjects with block sizes of 3 and 6 with proportion 1:1:1. A person from research team not involved in the recruitment and assigning participants generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops be used for allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants and investigators were blinded to type of intervention. Drugs and placebo were similar in the color and size and they were presented in dark bottles (A, B) coded by a subject who was not involved in any procedures of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University Of Medical Sciences
Street address
Shahrekord University Of Medical Sciences, Rahmatieh, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.SKUMS.REC.1396.174
Health conditions studied
1
Description of health condition studied
osteoporosis
ICD-10 code
M80
ICD-10 code description
Osteoporosis with current pathological fracture
Primary outcomes
1
Description
T score
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Bone densitometry
Secondary outcomes
1
Description
Bone density
Timepoint
At first visit and then 3 months after start of intevention
Method of measurement
Bone Densitometry
Intervention groups
1
Description
Intervention group: combined calcium and vitamin D (Ca-D3) supplement with loading dose of 400 International Unit(IU) of cholecalciferol and 500 mg calcium per day once daily,(23) and Osteofos tablet (70 mg) once a week also they consumed 1.5 Litter/day alkaline drinking water (pH = 8.6 ± 0.3)
Category
Treatment - Drugs
2
Description
Control group received Ca-D3 tablet daily and Osteofos tablet (70 mg/kg) once a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Subspecialty Clinic
Full name of responsible person
Dr Morteza Dehghan
Street address
Shariati Boulevard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Siavashfazelian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Siavashfazelian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
siavashfazelian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
siavashfazelian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
siavashfazelian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After ensuring that the participants are not identifiable, all potential data could be shared.
When the data will become available and for how long
6 months after article publication
To whom data/document is available
Researchers that are working at Shahre-kord University of Medical Sciences.
Under which criteria data/document could be used
In condition in which the priority of research innovation is not threatened.
From where data/document is obtainable
Sending the request to the corresponding author via email.
What processes are involved for a request to access data/document
The request is reviewed by the corresponding author and the decision will be made within 2 weeks of after receiving the request