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Magnesium Treatment in Hypoparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vallo Volke, University of Tartu
ClinicalTrials.gov Identifier:
NCT00824226
First received: January 15, 2009
Last updated: August 26, 2011
Last verified: August 2011
History of Changes
  Purpose
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.

Condition Intervention
Hypoparathyroidism
 Dietary Supplement: magnesium

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid Patients

Resource links provided by NLM:

MedlinePlus related topics: Calcium
Drug Information available for: Magnesium
U.S. FDA Resources

Further study details as provided by University of Tartu:

Primary Outcome Measures:
  • Calcium level at the end of magnesium treatment compared to pretreatment level [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calcium level after stopping treatment compared to the level at the end of magnesium treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Enrollment: 10
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: magnesium
    magnesium 350 mg tablets once a day for 3 weeks
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824226

Locations
Estonia
Tartu University Hospital
Tartu, Estonia, 50406
Sponsors and Collaborators
University of Tartu
Investigators
Principal Investigator: Vallo Volke, MD, PhD University of Tartu, Institute of Physiology
  More Information

Responsible Party: Vallo Volke, Dr., University of Tartu
ClinicalTrials.gov Identifier: NCT00824226     History of Changes
Other Study ID Numbers: UT296 
Study First Received: January 15, 2009
Last Updated: August 26, 2011
Health Authority: Estonia: The State Agency of Medicine

Keywords provided by University of Tartu:
primary hypoparathyroidism
secondary hypoparathyroidism
magnesium

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 27, 2016