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IRCT20170929036477N3 IRCT 2021-03-09 Shahre-kord University of Medical Sciences Effect of alkaline water on bone health Evaluation of the effect of alkaline drinking water on bone density in menopausal women with osteoporosis 2017-05-17 anticipated 100 Complete https://irct.ir/trial/54087 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 osteoporosis. Intervention 1: 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). Intervention 2: Control group received Ca-D3 tablet daily and Osteofos tablet (70 mg/kg) once a week. Yes - There is a plan to make this available What will be shared: After ensuring that the participants are not identifiable, all potential data could be shared. When: 6 months after article publication To whom: Researchers that are working at Shahre-kord University of Medical Sciences. Conditions: In condition in which the priority of research innovation is not threatened. Where to obtain: Sending the request to the corresponding author via email. How to obtain: The request is reviewed by the corresponding author and the decision will be made within 2 weeks of after receiving the request Comments:
public Dr Morteza Dehghan
Kashani Blvd
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3333 0061 siavashfazelian@yahoo.com Shahre-kord University of Medical Sciences scientific Dr Morteza Dehghan
Kashani Blvd
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3333 0061 siavashfazelian@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 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 30 years 75 years Female 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 M80 Osteoporosis with current pathological fracture Treatment - Drugs Treatment - Drugs 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) Control group received Ca-D3 tablet daily and Osteofos tablet (70 mg/kg) once a week. T score. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Bone densitometry. Bone density. Timepoint: At first visit and then 3 months after start of intevention. Method of measurement: Bone Densitometry. Shahrekord University of Medical Sciences Approved 2017-07-08 Ethics committee of Shahrekord University Of Medical Sciences Shahrekord University Of Medical Sciences, Rahmatieh, Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)