NCT02420119

Brief Summary

Intravenous iron therapy is common and effective, with few side effects. Two formulations are used, venofer or iron sucrose and ferrlecit, or ferric gluconate. The association between intravenous iron use and decrease in serum phosphorus and vitamin D levels, with increased fractional excretion of phosphorus, has been observed with older iron preparations, such as saccharated ferric oxide. However, hypophosphatemia and osteomalacia have been reported with iron carboxymaltose, a newer iron formulation. There is no information in the literature about phosphorus and vitamin D levels after treatment with venofer or ferrlecit. We intend to check phosphorus and vitamin D serum levels in our patients prior to and after treatment with these iron formulations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

August 9, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

April 14, 2015

Results QC Date

March 11, 2018

Last Update Submit

August 8, 2022

Conditions

Keywords

Iron Therapyserum phosphatesvitamin D

Outcome Measures

Primary Outcomes (1)

  • Decrease in Serum Levels of Phosphorus in Patients After Treatment With Intravenous Iron.

    serum phosphorus levels were measure at baseline, and after intravenous iron administration

    3 month

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

in a period of one year we will try to recruit approximately 100 men and women over the age of 18, who have iron deficiency anemia and have been prescribed intravenous iron treatment at the ambulatory treatment unit.

You may qualify if:

  • Age 18 and over
  • Have an indication for intravenous iron treatment
  • Estimated Creatinine clearance at least 30ml/min (patients with lower Estimated Creatinine clearance may not be able to excrete phosphorus)
  • Have signed informed consent.

You may not qualify if:

  • Pregnancy
  • Estimated creatinine clearance below 30 ml/min.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek medical center

Afula, Israel

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr.Frieda Wolf
Organization
HaEmek Medical Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr frieda wolf

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 9, 2022

Results First Posted

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations