Trial Outcomes & Findings for Weekly Zinc Chelate Supplementation on Children's Growth (NCT NCT01911260)
NCT ID: NCT01911260
Last Updated: 2013-12-24
Results Overview
Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ \< -1,5 Z-score), and Normal Height (HAZ between -1,0 and ±1,0 Z-score), and were randomly assigned to compose two exposed groups to receive a supplement of 30mg of zinc amino acid chelate, and two control groups to receive placebo individually once a week, during 12 weeks. Children's heights were measured at the End of Supplementation period and again after 12 weeks (Follow-up period). In combination with sex and age we transformed stature to Height-for-Age, expressed in Z-score, which was calculated as a number of standard deviations or Z-scores below or above the reference mean or median value, according to the formula below: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. We analyzed and discussed the change in HAZ (HAZ at the End of Follow-up period - HAZ at End of Supplementation).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
199 participants
Primary outcome timeframe
Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.
Results posted on
2013-12-24
Participant Flow
From original database of 2.519 children, enrolled in the first and second grades of four State-run public basic schools, we selected this study sample using height for age indicator (HAZ). Meetings were held at school with parents/guardians to explain the objective and procedures of the study in order to obtain a written consent.
From original database (n=2.519), we selected children with one and a half or more standard deviations below the mean height for age (HAZ) and gender of the reference population as Growth Deficit group. For the Normal Height group, HAZ was define as between -1 and +1 standard deviations from the mean height reference for age and sex (n=218).
Participant milestones
| Measure |
Growth Deficit+Zinc Amino Acid Chelate
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Growth Deficit + Placebo
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height+Zinc Amino Acid Chelate
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height + Placebo
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
|---|---|---|---|---|
|
Supplementation Period
STARTED
|
50
|
50
|
49
|
50
|
|
Supplementation Period
COMPLETED
|
40
|
38
|
39
|
42
|
|
Supplementation Period
NOT COMPLETED
|
10
|
12
|
10
|
8
|
|
Follow-up Period
STARTED
|
40
|
38
|
39
|
42
|
|
Follow-up Period
COMPLETED
|
27
|
18
|
24
|
30
|
|
Follow-up Period
NOT COMPLETED
|
13
|
20
|
15
|
12
|
Reasons for withdrawal
| Measure |
Growth Deficit+Zinc Amino Acid Chelate
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Growth Deficit + Placebo
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height+Zinc Amino Acid Chelate
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height + Placebo
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
|---|---|---|---|---|
|
Supplementation Period
transference or evasion of school
|
7
|
9
|
7
|
6
|
|
Supplementation Period
Adverse Event
|
2
|
0
|
1
|
0
|
|
Supplementation Period
refused to receive supplement
|
1
|
0
|
1
|
0
|
|
Supplementation Period
less than 12 weeks supplementation
|
0
|
3
|
1
|
2
|
|
Follow-up Period
transference or evasion of school
|
13
|
20
|
15
|
12
|
Baseline Characteristics
Weekly Zinc Chelate Supplementation on Children's Growth
Baseline characteristics by cohort
| Measure |
Growth Deficit+Zinc Amino Acid Chelate
n=50 Participants
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Growth Deficit + Placebo
n=50 Participants
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height+Zinc Amino Acid Chelate
n=49 Participants
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height + Placebo
n=50 Participants
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
199 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
|
7.63 years
STANDARD_DEVIATION 0.66 • n=5 Participants
|
7.64 years
STANDARD_DEVIATION 0.71 • n=7 Participants
|
7.63 years
STANDARD_DEVIATION 0.66 • n=5 Participants
|
7.64 years
STANDARD_DEVIATION 0.71 • n=4 Participants
|
7.63 years
STANDARD_DEVIATION 0.68 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
49 participants
n=5 Participants
|
50 participants
n=4 Participants
|
199 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ \< -1,5 Z-score), and Normal Height (HAZ between -1,0 and ±1,0 Z-score), and were randomly assigned to compose two exposed groups to receive a supplement of 30mg of zinc amino acid chelate, and two control groups to receive placebo individually once a week, during 12 weeks. Children's heights were measured at the End of Supplementation period and again after 12 weeks (Follow-up period). In combination with sex and age we transformed stature to Height-for-Age, expressed in Z-score, which was calculated as a number of standard deviations or Z-scores below or above the reference mean or median value, according to the formula below: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. We analyzed and discussed the change in HAZ (HAZ at the End of Follow-up period - HAZ at End of Supplementation).
Outcome measures
| Measure |
Growth Deficit+Zinc Amino Acid Chelate
n=27 Participants
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Growth Deficit + Placebo
n=18 Participants
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height+Zinc Amino Acid Chelate
n=24 Participants
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height + Placebo
n=30 Participants
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
|---|---|---|---|---|
|
Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period.
|
0.04 Z-Score
Standard Deviation 0.12
|
-0.08 Z-Score
Standard Deviation 0.45
|
0.10 Z-Score
Standard Deviation 0.15
|
0.02 Z-Score
Standard Deviation 0.26
|
Adverse Events
Growth Deficit+Zinc Amino Acid Chelate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Growth Deficit Receiving Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Height+Zinc Amino Acid Chelate
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Height Receiving Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Growth Deficit+Zinc Amino Acid Chelate
n=50 participants at risk
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Growth Deficit Receiving Placebo
n=50 participants at risk
Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height+Zinc Amino Acid Chelate
n=49 participants at risk
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
Normal Height Receiving Placebo
n=50 participants at risk
For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal event
|
4.0%
2/50 • Number of events 2 • Adverse event data were collected during 12 weeks.
In the collection data spread sheet, there was a column for side effects (yes/no), and type of side effects (description given by the subject).
|
0.00%
0/50 • Adverse event data were collected during 12 weeks.
In the collection data spread sheet, there was a column for side effects (yes/no), and type of side effects (description given by the subject).
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected during 12 weeks.
In the collection data spread sheet, there was a column for side effects (yes/no), and type of side effects (description given by the subject).
|
0.00%
0/50 • Adverse event data were collected during 12 weeks.
In the collection data spread sheet, there was a column for side effects (yes/no), and type of side effects (description given by the subject).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place