Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50). (parathormon)
Primary Purpose
Unspecified Disorder of Bone Density and Structure
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Oral magnesium substitution
Placebo tablets without magnesium
Sponsored by
About this trial
This is an interventional health services research trial for Unspecified Disorder of Bone Density and Structure focused on measuring calcium, magnesium, vitamin D, bone turnover markers
Eligibility Criteria
Inclusion Criteria:
Homeliving healthy female volunteers aged 70 years old were recruited by phone.
Exclusion Criteria:
Persons who had used:
- biphosphonates,
- oestrogens,
- glucocortocoids,
- antiepileptic drugs,
- diuretics,
- immunmodulating agents,
- prolonged usage of heparin.
- patients with possible secondary osteoporosis and
diagnosis as:
- inflammatory bowel disease,
- primary hyperthyroidisms,
- chronic obstructive lung disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Oral magnesium substitution
Magnesium + or Magnesium -
Arm Description
Daily 240 mg Magnesium Nycomed Pharma. Intervention day 0 - day 28.
Placebo tablets without magnesium.
Outcomes
Primary Outcome Measures
Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)
Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)
Mg induced changes from day 0-28 on s-calcidiol (nmol/L)
Mg induced changes from day 0-28 on s-calcitriol (pmol/L)
Mg induced changes from day 0-28 on s-PTH ( pmol/L)
Mg induced changes from day 0-28 on s-Bone ALP (u/L)
Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)
Mg induced changes from day 0-28 on s- 1-CTP (ug/L)
Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)
Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)
Secondary Outcome Measures
Full Information
NCT ID
NCT02549521
First Posted
November 22, 2014
Last Updated
September 14, 2015
Sponsor
Oslo University Hospital
Collaborators
Nycomed
1. Study Identification
Unique Protocol Identification Number
NCT02549521
Brief Title
Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50).
Acronym
parathormon
Official Title
Magnesium Supplementation in Elderly Females
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Nycomed
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Calcium and vitamin D substitution has for a long time been used to improve osteoporosis.The main storage place for magnesium is in the bone. Magnesium is direct under calcium in the periodic system making it possible to interact with the crystal structure. Some small studies have shown beneficial effects of magnesium substitution on osteoporosis. Evidence has shown improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. It has been uncertain however, which of these factors can contribute to such a change. The effect of magnesium substitution 240 mg daily as therefore studied in two parallel groups where both received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got placebo and the other received magnesium. This was studied on various expressions for bone metabolism after zero, seven and 28 days in elderly females aged 70 years old.
Detailed Description
Elderly 70 year old ladies who had been to an outpatient X-ray investigation were invited to participate in this study. They were all healthy without any signs of osteoporosis, or fractures.They were stimulated to participate by having done bone density measurements free. Patients who had used biphosphonates, oestrogens, glucocorticoids , diuretics, immunomodulating agents, or prolonged use of heparin were excluded.
Patients with possible secondary osteoporosis due to primary hyperthyroidism or chronic lung disease were also excluded. The participants were randomized into placebo or Mg-treatment groups. They were seen by the dietician, and blood and urine samples were taken at day 0, 7 and 28 at the same time these days. Medicine was prepacked for intake twice daily. They received medicine for 30 days and should only take for 28 days. The number of tablets which should be left was controlled the last day. The participants were informed about the results of the bone density measurements taken the first and the last day. All the patient contacts were undertaken by the same dietician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Disorder of Bone Density and Structure
Keywords
calcium, magnesium, vitamin D, bone turnover markers
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral magnesium substitution
Arm Type
Active Comparator
Arm Description
Daily 240 mg Magnesium Nycomed Pharma. Intervention day 0 - day 28.
Arm Title
Magnesium + or Magnesium -
Arm Type
Placebo Comparator
Arm Description
Placebo tablets without magnesium.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral magnesium substitution
Intervention Description
The elderly was given tablets two times daily with calsium and vitamin D. They were further given magnesium tablets 120 mg two times daily for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablets without magnesium
Intervention Description
The elderly was given tablets two times daily with calsium and vitamin D. They were further given placebo without magnesium two times daily for 28 days.
Primary Outcome Measure Information:
Title
Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on s-calcidiol (nmol/L)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on s-calcitriol (pmol/L)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on s-PTH ( pmol/L)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on s-Bone ALP (u/L)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on s- 1-CTP (ug/L)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)
Time Frame
28 days
Title
Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)
Time Frame
28 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Homeliving healthy female volunteers aged 70 years old were recruited by phone.
Exclusion Criteria:
Persons who had used:
biphosphonates,
oestrogens,
glucocortocoids,
antiepileptic drugs,
diuretics,
immunmodulating agents,
prolonged usage of heparin.
patients with possible secondary osteoporosis and
diagnosis as:
inflammatory bowel disease,
primary hyperthyroidisms,
chronic obstructive lung disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bøhmer, MD, PhD.
Organizational Affiliation
University Hospital, Aker
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50).
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