NCT00824226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

2.6 years

First QC Date

January 15, 2009

Last Update Submit

August 26, 2011

Conditions

Hypoparathyroidism

Keywords

primary hypoparathyroidismsecondary hypoparathyroidismmagnesium

Outcome Measures

Primary Outcomes (1)

  • Calcium level at the end of magnesium treatment compared to pretreatment level

    3 weeks

Secondary Outcomes (1)

  • Calcium level after stopping treatment compared to the level at the end of magnesium treatment

    2 weeks

Interventions

magnesiumDIETARY_SUPPLEMENT

magnesium 350 mg tablets once a day for 3 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • any other disease known to influence plasma Ca level
  • pregnancy
  • creatinine \> 150 microM/L
  • patient has used supplementary magnesium within 2 previous months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, 50406, Estonia

Location

MeSH Terms

Conditions

Hypoparathyroidism

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Vallo Volke, MD, PhD

    University of Tartu, Institute of Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 29, 2011

Record last verified: 2011-08

Locations

ES(1)