Trial Outcomes & Findings for Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia (NCT NCT01904864)

NCT ID: NCT01904864

Last Updated: 2017-12-14

Results Overview

The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment. The primary analysis consists of a linear mixed regression model, which incorporates all subsequent time points into the model and includes treatment and time as covariates and patient random effects to account for correlation among longitudinal measurements from the same patients.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	NovaFerrum® (Iron Polysaccharide Complex) Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.	Ferrous Sulfate Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
Overall Study STARTED	40	40
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NovaFerrum® (Iron Polysaccharide Complex) n=40 Participants Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.	Ferrous Sulfate n=40 Participants Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.	Total n=80 Participants Total of all reporting groups
Age, Continuous	23 Months n=5 Participants	22 Months n=7 Participants	23 Months n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic white	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic white	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized >1 Race/ethnicity	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	NovaFerrum® (Iron Polysaccharide Complex) n=40 Participants Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.	Ferrous Sulfate n=40 Participants Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
Hemoglobin Concentration Over Time 4 Weeks	9.3 g/dL Standard Deviation 1.4	10.4 g/dL Standard Deviation 1.3
Hemoglobin Concentration Over Time Baseline	7.7 g/dL Standard Deviation 1.6	7.9 g/dL Standard Deviation 1.5
Hemoglobin Concentration Over Time 8 Weeks	10.5 g/dL Standard Deviation 1.3	11.4 g/dL Standard Deviation 1.3
Hemoglobin Concentration Over Time 12 Weeks	11.1 g/dL Standard Deviation 1.2	11.9 g/dL Standard Deviation 1.2

Adverse Events

NovaFerrum® (Iron Polysaccharide Complex)

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Ferrous Sulfate

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NovaFerrum® (Iron Polysaccharide Complex) n=40 participants at risk Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.	Ferrous Sulfate n=40 participants at risk Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
Blood and lymphatic system disorders Methemoglobinemia	0.00% 0/40	2.5% 1/40 • Number of events 1

Other adverse events

Other adverse events
Measure	NovaFerrum® (Iron Polysaccharide Complex) n=40 participants at risk Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation of an iron polysaccharide complex (NovaFerrum®), for 12 weeks.	Ferrous Sulfate n=40 participants at risk Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
Gastrointestinal disorders Gastrointestinal	80.0% 32/40 • Number of events 32	72.5% 29/40 • Number of events 29

Additional Information

Jacquelyn M. Powers, MD

Baylor College of Medicine

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place