Back to resultsMagnesium Treatment in Hypoparathyroidism
Primary Purpose
Hypoparathyroidism
Status
Completed
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
magnesium
Sponsored by
About this trial
This is an interventional treatment trial for Hypoparathyroidism focused on measuring primary hypoparathyroidism, secondary hypoparathyroidism, magnesium
Eligibility Criteria
Inclusion Criteria:
- primary or secondary hypoparathyroidism
- treatment with calcium plus vitamin D analogue
- ionized calcium 1,0-1,29 mmol/L
- magnesium level 0,7-1,05 mmol/L
- TSH 0.1- 10 imU/L
Exclusion Criteria:
- any other disease known to influence plasma Ca level
- pregnancy
- creatinine > 150 microM/L
- patient has used supplementary magnesium within 2 previous months
Sites / Locations
- Tartu University Hospital
Outcomes
Primary Outcome Measures
Calcium level at the end of magnesium treatment compared to pretreatment level
Secondary Outcome Measures
Calcium level after stopping treatment compared to the level at the end of magnesium treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00824226
Brief Title
Magnesium Treatment in Hypoparathyroidism
Official Title
Effect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tartu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study hypothesis: supplementary magnesium may influence the blood calcium level in treated hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day) for 3 weeks. Calcium and other relevant blood parameters will be measured before the treatment, at the end of treatment and 2 weeks after stopping treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoparathyroidism
Keywords
primary hypoparathyroidism, secondary hypoparathyroidism, magnesium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
magnesium
Intervention Description
magnesium 350 mg tablets once a day for 3 weeks
Primary Outcome Measure Information:
Title
Calcium level at the end of magnesium treatment compared to pretreatment level
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Calcium level after stopping treatment compared to the level at the end of magnesium treatment
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary or secondary hypoparathyroidism
treatment with calcium plus vitamin D analogue
ionized calcium 1,0-1,29 mmol/L
magnesium level 0,7-1,05 mmol/L
TSH 0.1- 10 imU/L
Exclusion Criteria:
any other disease known to influence plasma Ca level
pregnancy
creatinine > 150 microM/L
patient has used supplementary magnesium within 2 previous months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vallo Volke, MD, PhD
Organizational Affiliation
University of Tartu, Institute of Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
12. IPD Sharing Statement
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Magnesium Treatment in Hypoparathyroidism
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