Trial Outcomes & Findings for Does Intravenous Iron Therapy Decrease Serum Phosphorous Levels? (NCT NCT02420119)
NCT ID: NCT02420119
Last Updated: 2022-08-09
Results Overview
serum phosphorus levels were measure at baseline, and after intravenous iron administration
Recruitment status
COMPLETED
Target enrollment
53 participants
Primary outcome timeframe
3 month
Results posted on
2022-08-09
Participant Flow
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.
Participant milestones
| Measure |
Self-control Observational Cohort
48 subjects with iron deficiency anemia, had serum phosphorus levels checked before and after administration of intravenous iron.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Self-control Observational Cohort
48 subjects with iron deficiency anemia, had serum phosphorus levels checked before and after administration of intravenous iron.
|
|---|---|
|
Overall Study
insufficient laboratory data
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Receiving Intravenous Iron
n=48 Participants
patients over the age of 18 with iron deficiency anemia, who were referred for intravenous iron treatment, who gave consent to participate
|
|---|---|
|
Age, Continuous
|
49.83 years
STANDARD_DEVIATION 14.8 • n=48 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=48 Participants
|
|
Region of Enrollment
Israel
|
48 participants
n=48 Participants
|
|
serum phosphorus levels
|
3.46 mg/dL
STANDARD_DEVIATION 0.5 • n=48 Participants
|
|
vitamin D levels
|
40.67 nmol/L
STANDARD_DEVIATION 23.4 • n=43 Participants • missing information regarding 5 participants
|
|
eGFR
|
113 ml/min
STANDARD_DEVIATION 44.4 • n=25 Participants • missing data
|
PRIMARY outcome
Timeframe: 3 monthserum phosphorus levels were measure at baseline, and after intravenous iron administration
Outcome measures
| Measure |
Self-control Observational Cohort
n=48 Participants
48 subjects with iron deficiency anemia, had serum phosphorus levels checked before and after administration of intravenous iron.
|
|---|---|
|
Decrease in Serum Levels of Phosphorus in Patients After Treatment With Intravenous Iron.
|
3.47 mg/dL
Standard Deviation 0.55
|
Adverse Events
Self-control Observational Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place