Trial Outcomes & Findings for Iron Treatment for Young Children With Non-anemic Iron Deficiency (NCT NCT01481766)
NCT ID: NCT01481766
Last Updated: 2025-10-30
Results Overview
ELC is a measure of infant cognition (similar to IQ). In populations, infants have a mean score of 100 points and standard deviation of 15 points. A higher score indicates higher cognitive ability. Four cognitive skills are summarized into an Early Learning Composite score - Fine Motor, Visual Reception, Receptive Language, and Expressive Language.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
127 participants
Primary outcome timeframe
Baseline and 4 months after enrollment
Results posted on
2025-10-30
Participant Flow
Healthy children were enrolled while attending a scheduled health supervision visit at 1 of 8 primary care practices participating in a primary care research network called TARGet Kids! in Toronto, Canada. Enrollment began on June 15, 2012, and data collection was completed on November 9, 2018.
220 children were assessed for eligibility. Based on each child's baseline blood tests (hemoglobin and ferritin), children with nonanemic iron deficiency (NAID) were eligible for the randomized trial; and children with iron deficiency anemia (IDA) and iron sufficiency (IS) were eligible for the open label study (not randomized). Therefore, 60 children were eligible for the randomized arms; 67 children were eligible for the open label study (not randomized). The total enrolled was 127 children.
Participant milestones
| Measure |
Non-anemic iron deficiency - randomized to ferrous sulfate plus diet advice
liquid ferrous sulfate (6 mg elemental iron/kg/d, Fer-In-Sol, supplied by Mead Johnson Nutrition) in 2 divided doses daily by mouth for 4 months plus diet advice (parents received a written guide, developed by the investigators, for improving iron status including recommendations on iron-containing foods, foods that increase and inhibit iron absorption, and feeding practices that may prevent iron deficiency)
|
Non-anemic iron deficiency randomized to placebo plus diet advice
liquid placebo in 2 divided doses daily by mouth for 4 months plus diet advice (parents received a written guide, developed by the investigators, for improving iron status including recommendations on iron-containing foods, foods that increase and inhibit iron absorption, and feeding practices that may prevent iron deficiency)
|
Iron sufficient - not randomized
Normal hemoglobin and normal ferritin. No treatment.
|
Iron deficiency anemia - not randomized
Low hemoglobin and low ferritin. Received oral iron and diet advice for 4 months
|
|---|---|---|---|---|
|
4 months
STARTED
|
31
|
29
|
30
|
37
|
|
4 months
COMPLETED
|
28
|
27
|
29
|
32
|
|
4 months
NOT COMPLETED
|
3
|
2
|
1
|
5
|
|
12 months
STARTED
|
28
|
27
|
29
|
32
|
|
12 months
COMPLETED
|
21
|
19
|
24
|
29
|
|
12 months
NOT COMPLETED
|
7
|
8
|
5
|
3
|
Reasons for withdrawal
| Measure |
Non-anemic iron deficiency - randomized to ferrous sulfate plus diet advice
liquid ferrous sulfate (6 mg elemental iron/kg/d, Fer-In-Sol, supplied by Mead Johnson Nutrition) in 2 divided doses daily by mouth for 4 months plus diet advice (parents received a written guide, developed by the investigators, for improving iron status including recommendations on iron-containing foods, foods that increase and inhibit iron absorption, and feeding practices that may prevent iron deficiency)
|
Non-anemic iron deficiency randomized to placebo plus diet advice
liquid placebo in 2 divided doses daily by mouth for 4 months plus diet advice (parents received a written guide, developed by the investigators, for improving iron status including recommendations on iron-containing foods, foods that increase and inhibit iron absorption, and feeding practices that may prevent iron deficiency)
|
Iron sufficient - not randomized
Normal hemoglobin and normal ferritin. No treatment.
|
Iron deficiency anemia - not randomized
Low hemoglobin and low ferritin. Received oral iron and diet advice for 4 months
|
|---|---|---|---|---|
|
4 months
Lost to Follow-up
|
3
|
2
|
1
|
5
|
|
12 months
Lost to Follow-up
|
7
|
8
|
5
|
3
|
Baseline Characteristics
Iron Treatment for Young Children With Non-anemic Iron Deficiency
Baseline characteristics by cohort
| Measure |
NAID - Iron Plus Diet Advice
n=31 Participants
From the screening cohort, children with NAID (nonanemic iron deficiency) were invited to participate in an RCT. This group was randomized to receive Ferrous Sulfate 6 mg elemental iron/kg/day in 2 divided doses for four months plus diet advice
|
NAID - Placebo Plus Diet Advice
n=29 Participants
From the screening cohort, children with NAID (nonanemic iron deficiency) were invited to participate in an RCT. This group was randomized to receive Placebo in 2 divided doses for four months plus diet advice
|
IS - Iron Sufficient
n=30 Participants
From the screening cohort, a random sample of children with Iron Sufficiency were invited to participate in a prospective observational arm. They received diet advice only.
|
IDA - Iron Deficiency Anemia
n=37 Participants
From the screening cohort, children with Iron Deficiency Anemia (IDA) were invited to participate in a prospective observational arm. They received usual care, including Ferrous Sulfate 6 mg elemental iron/kg/day in 2 divided doses for four months plus diet advice.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
24.0 months
STANDARD_DEVIATION 8.1 • n=5 Participants
|
24.5 months
STANDARD_DEVIATION 6.6 • n=7 Participants
|
27.97 months
STANDARD_DEVIATION 8.70 • n=5 Participants
|
20.32 months
STANDARD_DEVIATION 6.13 • n=4 Participants
|
23.97 months
STANDARD_DEVIATION 7.32 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Maternal Ethnicity · other European
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Maternal Ethnicity · Other
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
30 participants
n=5 Participants
|
37 participants
n=4 Participants
|
127 participants
n=21 Participants
|
|
Early Learning Composite (ELC)
|
108.7 points
STANDARD_DEVIATION 15.2 • n=5 Participants
|
109.2 points
STANDARD_DEVIATION 14.9 • n=7 Participants
|
106.33 points
STANDARD_DEVIATION 10.55 • n=5 Participants
|
103.73 points
STANDARD_DEVIATION 12.82 • n=4 Participants
|
106.81 points
STANDARD_DEVIATION 13.26 • n=21 Participants
|
|
Serum Ferritin
|
9.7 ug/L
STANDARD_DEVIATION 2.3 • n=5 Participants
|
10.1 ug/L
STANDARD_DEVIATION 2.5 • n=7 Participants
|
26.63 ug/L
STANDARD_DEVIATION 10.84 • n=5 Participants
|
7.14 ug/L
STANDARD_DEVIATION 3.22 • n=4 Participants
|
13.04 ug/L
STANDARD_DEVIATION 4.63 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 months after enrollmentPopulation: ELC 4 months after enrollment
ELC is a measure of infant cognition (similar to IQ). In populations, infants have a mean score of 100 points and standard deviation of 15 points. A higher score indicates higher cognitive ability. Four cognitive skills are summarized into an Early Learning Composite score - Fine Motor, Visual Reception, Receptive Language, and Expressive Language.
Outcome measures
| Measure |
NAID - ferrous sulfate plus diet advice
n=28 Participants
Ferrous sulfate plus diet advice
|
NAID - placebo plus diet advice
n=27 Participants
Placebo plus diet advice
|
Iron sufficient
n=29 Participants
Diet advice only
|
Iron deficiency anemia
n=32 Participants
Ferrous sulfate plus diet advice
|
|---|---|---|---|---|
|
Early Learning Composite (ELC) From the Mullen Scales of Early Learning
|
113.0 units on a scale
Standard Deviation 19.3
|
113.5 units on a scale
Standard Deviation 12.6
|
110.48 units on a scale
Standard Deviation 10.16
|
107.94 units on a scale
Standard Deviation 13.69
|
SECONDARY outcome
Timeframe: 4 months after enrollmentBlood samples analyzed for serum ferritin
Outcome measures
| Measure |
NAID - ferrous sulfate plus diet advice
n=28 Participants
Ferrous sulfate plus diet advice
|
NAID - placebo plus diet advice
n=27 Participants
Placebo plus diet advice
|
Iron sufficient
n=30 Participants
Diet advice only
|
Iron deficiency anemia
n=33 Participants
Ferrous sulfate plus diet advice
|
|---|---|---|---|---|
|
Serum Ferritin
|
37.8 ug/L
Standard Deviation 30.8
|
20.4 ug/L
Standard Deviation 11.2
|
27.13 ug/L
Standard Deviation 9.06
|
57.55 ug/L
Standard Deviation 40.44
|
Adverse Events
NAID - Iron plus diet advice
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
NAID - Placebo plus diet advice
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
IS - Iron sufficient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IDA - Iron deficiency anemia
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NAID - Iron plus diet advice
n=28 participants at risk
From the screening cohort, children with NAID (nonanemic iron deficiency) were invited to participate in an RCT. This group was randomized to receive Ferrous Sulfate 6 mg elemental iron/kg/day in 2 divided doses for four months plus diet advice
|
NAID - Placebo plus diet advice
n=27 participants at risk
From the screening cohort, children with NAID (nonanemic iron deficiency) were invited to participate in an RCT. This group was randomized to receive Placebo in 2 divided doses for four months plus diet advice
|
IS - Iron sufficient
n=29 participants at risk
From the screening cohort, a random sample of children with Iron Sufficiency were invited to participate in a prospective observational arm. They received diet advice only.
|
IDA - Iron deficiency anemia
n=32 participants at risk
From the screening cohort, children with Iron Deficiency Anemia (IDA) were invited to participate in a prospective observational arm. They received usual care, including Ferrous Sulfate 6 mg elemental iron/kg/day in 2 divided doses for four months plus diet advice.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Change in stool
|
57.1%
16/28 • Number of events 16 • 4 months
|
25.9%
7/27 • Number of events 7 • 4 months
|
0.00%
0/29 • 4 months
|
50.0%
16/32 • Number of events 16 • 4 months
|
Additional Information
Dr. Patricia Parkin
Hospital for Sick Children, Toronto, Canada
Phone: 416-81307654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place