Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Intravenous Iron Therapy Decrease Serum Phosphorous Levels?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02420119
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Frieda Wolf, HaEmek Medical Center, Israel

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.


Condition or disease Intervention/treatment
Chronic Renal Failure Other: non interventional

Detailed Description:

Intravenous iron replacement has become quite common in cases where oral iron therapy is insufficient or poorly tolerated. Various intravenous iron preparations have been used in patients on dialysis and with chronic kidney disease for many years, however, these patients have severely reduced glomerular filtration rate and are generally hyperphosphatemic.

Although generally safe, certain iron preparations have been associated with severe phosphorus and calcitriol deficiency, caused by elevation in serum levels of fgf23, a phosphaturic humoral factor derived from osteocytes. Fractional excretion of phosphorus is indeed raised in these patients. In some cases phosphorus deficiency, or high fgf23 levels, are so severe that osteomalacia can result . This phenomenon has been observed with saccharated ferric oxide , a preparation commonly used in Japan, and in iron polymaltose . It has also been observed with iron carboxymaltose , a newer iron preparation, now available in Israel. These reports propose that iron causes elevated fgf23 levels, which in turn decreases phosphorus absorption and inhibits 1α-hydroxylase activity. Patients with deficient vitamin D have greater tendency to develop hypophosphatemia.

This phenomenon of phosphorus deficiency has not been documented in the commonly used preparations of iron sucrose (venofer) and ferric gluconate (ferrlecit). These non-dextran iron preparations have a very low rate of allergic reactions and adverse events. They are used in various cases of iron deficiency anemia with normal renal function, such as patients with Inflammatory bowel disease , diabetics or in people who cannot tolerate oral iron therapy. Moreover, certain oral iron preparations are under investigation at present for their role as phosphorus binders.

The purpose of this study is to measure phosphorus, parathyroid hormone and vitamin D levels in patients prior to and after intravenous iron therapy in patients with iron deficiency anemia with normal and reduced Glomerular Filtration Rate . We hypothesize that iron therapy with ferric gluconate and iron sucrose will induce hypophosphatemia and low levels of 1,25 hydroxide Vit D. We will try to ascertain whether the hypophosphatemia is clinically significant or merely a low laboratory value, and whether patients with vitamin 25 hydroxide -D deficiency have a greater propensity to develop it.


Layout table for study information
Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Intravenous Iron Therapy Decrease Serum Phosphorous and Vitamin D Levels in Patients With and Without Chronic Renal Failure?
Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. decrease in serum levels of phosphorus and 1,25hydroxide vitamin D in patients after treatment with intravenous iron. [ Time Frame: 3 month ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420119


Locations
Layout table for location information
Israel
Haemek medical center
Afula, Israel
Sponsors and Collaborators
Frieda Wolf

Layout table for additonal information
Responsible Party: Frieda Wolf, Dr frieda wolf, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02420119     History of Changes
Other Study ID Numbers: EMC 59-14
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Frieda Wolf, HaEmek Medical Center, Israel:
Iron Therapy
serum phosphates
vitamin D
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents