NCT01854437

Brief Summary

Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

May 4, 2013

Last Update Submit

May 12, 2013

Conditions

Hyperphosphatemia

Keywords

mg oxidehyperphosphatemiaplasma phosphor level

Outcome Measures

Primary Outcomes (1)

  • plasma phosphate level

    4 week

Study Arms (2)

Mg Oxide

Mg Oxide (Mg®, 21st Century®) 250 mg orally for 4 weeks

Drug: Mg Oxide

placebo

placebo 1 tab TDS

Interventions

Mg OxideDRUG

250 mg orally for 4 weeks

Also known as: (Mg®, 21st Century®)
Mg Oxide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

hemodialysis patients

You may qualify if:

  • hemodialysis with duration\>3 months serum P level \>5.5 mg/dl serum Ca\>8 mg/dl.

You may not qualify if:

  • Mg level \>3 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University Hemodialysis Center

Shiraz, Fars, o98-711, Iran

Location

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor of shiraz Shiraz University of Medical Sciences

Study Record Dates

First Submitted

May 4, 2013

First Posted

May 15, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

IR(1)