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Does Intravenous Iron Therapy Decrease Serum Phosphorous Levels?

Does Intravenous Iron Therapy Decrease Serum Phosphorous and Vitamin D Levels in Patients With and Without Chronic Renal Failure?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02420119
Enrollment
53
Registered
2015-04-17
Start date
2015-01-31
Completion date
2016-01-31
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

Keywords

Iron Therapy, serum phosphates, vitamin D

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.

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.

Interventions

OTHERnon interventional

Sponsors

Frieda Wolf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Decrease in Serum Levels of Phosphorus in Patients After Treatment With Intravenous Iron.3 monthserum phosphorus levels were measure at baseline, and after intravenous iron administration

Countries

Israel

Participant flow

Pre-assignment details

In order to show a mean difference of 0.16 mmol/L for serum phosphorus before and after treatment, samples from 23 patients were needed . we recruited more patients than were needed to demonstrate this difference.

Participants by arm

ArmCount
Patients Receiving Intravenous Iron
patients over the age of 18 with iron deficiency anemia, who were referred for intravenous iron treatment, who gave consent to participate
48
Total48

Withdrawals & dropouts

PeriodReasonFG000
Overall Studyinsufficient laboratory data5

Baseline characteristics

CharacteristicPatients Receiving Intravenous Iron
Age, Continuous49.83 years
STANDARD_DEVIATION 14.8
eGFR113 ml/min
STANDARD_DEVIATION 44.4
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Israel
48 participants
serum phosphorus levels3.46 mg/dL
STANDARD_DEVIATION 0.5
Sex: Female, Male
Female
43 Participants
Sex: Female, Male
Male
5 Participants
vitamin D levels40.67 nmol/L
STANDARD_DEVIATION 23.4

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 53
serious
Total, serious adverse events
0 / 53

Outcome results

Primary

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

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Self-control Observational CohortDecrease in Serum Levels of Phosphorus in Patients After Treatment With Intravenous Iron.3.47 mg/dLStandard Deviation 0.55

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026