Trial Outcomes & Findings for Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years (NCT NCT00907088)
NCT ID: NCT00907088
Last Updated: 2014-04-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
251 participants
Primary outcome timeframe
Age 24 months
Results posted on
2014-04-16
Participant Flow
Participant milestones
| Measure |
Control Group
Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
|
Intervention Group
Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
129
|
|
Overall Study
COMPLETED
|
102
|
99
|
|
Overall Study
NOT COMPLETED
|
20
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years
Baseline characteristics by cohort
| Measure |
Control Group
n=122 Participants
Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel based on the Canadian Paediatric Society Guidelines. Nutrition counselling occurs at the 9-month visit and is repeated at the 15-month visit if the child has not transitioned into the use of a cup. Recommendations include iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
|
Intervention Group
n=129 Participants
Healthy milk intake: In addition to the standard nutrition counselling provided in the control group, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
122 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
251 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
85 participants
n=99 Participants
|
92 participants
n=107 Participants
|
177 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 participants
n=99 Participants
|
12 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 participants
n=99 Participants
|
18 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Bottle use
Breast Only
|
46 participants
n=99 Participants
|
38 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Bottle use
Bottle Only
|
60 participants
n=99 Participants
|
61 participants
n=107 Participants
|
121 participants
n=206 Participants
|
|
Bottle use
Breast and Bottle
|
15 participants
n=99 Participants
|
26 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Bottle use
Information Not Available
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Plan to bottle-wean by 2 years old
Plan to Bottle Wean By 2 Years Old
|
67 participants
n=99 Participants
|
63 participants
n=107 Participants
|
130 participants
n=206 Participants
|
|
Plan to bottle-wean by 2 years old
No Information Available
|
55 participants
n=99 Participants
|
66 participants
n=107 Participants
|
121 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Age 24 monthsOutcome measures
| Measure |
Control Group
n=99 Participants
Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
|
Intervention Group
n=102 Participants
Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
|
|---|---|---|
|
The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.
Yes Iron Depletion
|
13 participants
|
10 participants
|
|
The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.
No Iron Depletion
|
64 participants
|
71 participants
|
|
The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.
Unknown
|
22 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Age 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Age 24 monthsOutcome measures
Outcome data not reported
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
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