Trial Outcomes & Findings for Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes (NCT NCT00470158)
NCT ID: NCT00470158
Last Updated: 2018-04-20
Results Overview
A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1000 participants
Primary outcome timeframe
6 months
Results posted on
2018-04-20
Participant Flow
All 6-18 month old permanent residents of selected villages near Kumudini Hospital were enrolled from May 8, 2007-August 31, 2007.
If one family had two eligible children, one was randomly selected for enrollment. Children with severe malnutrition (weight for height z-score -3 s.d.), severe anemia (hemoglobin \<70 g/l), chronic illnesses that would impair feeding ability, planned move during the study period, or active fever (\>38.5 C) were excluded from the study.
Participant milestones
| Measure |
Combined Iron and Zinc
combined iron and zinc, alternating daily with placebo
|
Separate Iron and Zinc
iron, alternating daily with zinc
|
Iron Alone
iron, alternating daily with placebo
|
Zinc Alone
zinc, alternating daily with placebo
|
Placebo
placebo daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
201
|
199
|
201
|
198
|
201
|
|
Overall Study
COMPLETED
|
193
|
191
|
193
|
193
|
195
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
8
|
5
|
6
|
Reasons for withdrawal
| Measure |
Combined Iron and Zinc
combined iron and zinc, alternating daily with placebo
|
Separate Iron and Zinc
iron, alternating daily with zinc
|
Iron Alone
iron, alternating daily with placebo
|
Zinc Alone
zinc, alternating daily with placebo
|
Placebo
placebo daily
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
8
|
5
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes
Baseline characteristics by cohort
| Measure |
Combined Iron and Zinc
n=201 Participants
combined iron and zinc, alternating daily with placebo
|
Separate Iron and Zinc
n=199 Participants
iron, alternating daily with zinc
|
Iron Alone
n=201 Participants
iron, alternating daily with placebo
|
Zinc Alone
n=198 Participants
zinc, alternating daily with placebo
|
Placebo
n=201 Participants
placebo daily
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
201 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
201 Participants
n=206 Participants
|
198 Participants
n=7 Participants
|
201 Participants
n=31 Participants
|
1000 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
0.93 years
STANDARD_DEVIATION 0.31 • n=99 Participants
|
0.925 years
STANDARD_DEVIATION 0.32 • n=107 Participants
|
0.9 years
STANDARD_DEVIATION 0.33 • n=206 Participants
|
0.925 years
STANDARD_DEVIATION 0.33 • n=7 Participants
|
0.9 years
STANDARD_DEVIATION 0.32 • n=31 Participants
|
0.92 years
STANDARD_DEVIATION 0.32 • n=30 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
109 Participants
n=7 Participants
|
88 Participants
n=31 Participants
|
484 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
89 Participants
n=7 Participants
|
113 Participants
n=31 Participants
|
516 Participants
n=30 Participants
|
|
Region of Enrollment
Bangladesh
|
201 participants
n=99 Participants
|
199 participants
n=107 Participants
|
201 participants
n=206 Participants
|
198 participants
n=7 Participants
|
201 participants
n=31 Participants
|
1000 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 6 monthsA diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.
Outcome measures
| Measure |
Combined Iron and Zinc
n=201 Participants
combined iron and zinc, alternating daily with placebo
|
Separate Iron and Zinc
n=199 Participants
iron, alternating daily with zinc
|
Iron Alone
n=201 Participants
iron, alternating daily with placebo
|
Zinc Alone
n=198 Participants
zinc, alternating daily with placebo
|
Placebo
n=201 Participants
placebo daily
|
|---|---|---|---|---|---|
|
Incidence of Diarrhea
|
201 episodes
|
204 episodes
|
260 episodes
|
224 episodes
|
235 episodes
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Combined Iron and Zinc
Serious events: 11 serious events
Other events: 2 other events
Deaths: 0 deaths
Separate Iron and Zinc
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
Iron Alone
Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths
Zinc Alone
Serious events: 10 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 22 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Iron and Zinc
n=201 participants at risk
combined iron and zinc, alternating daily with placebo
|
Separate Iron and Zinc
n=199 participants at risk
iron, alternating daily with zinc
|
Iron Alone
n=201 participants at risk
iron, alternating daily with placebo
|
Zinc Alone
n=198 participants at risk
zinc, alternating daily with placebo
|
Placebo
n=201 participants at risk
placebo daily
|
|---|---|---|---|---|---|
|
Infections and infestations
infectious hospitalizations
|
5.5%
11/201
|
4.0%
8/199
|
8.5%
17/201
|
5.1%
10/198
|
10.9%
22/201
|
Other adverse events
| Measure |
Combined Iron and Zinc
n=201 participants at risk
combined iron and zinc, alternating daily with placebo
|
Separate Iron and Zinc
n=199 participants at risk
iron, alternating daily with zinc
|
Iron Alone
n=201 participants at risk
iron, alternating daily with placebo
|
Zinc Alone
n=198 participants at risk
zinc, alternating daily with placebo
|
Placebo
n=201 participants at risk
placebo daily
|
|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
noninfectious hospitalizations
|
1.00%
2/201
|
1.0%
2/199
|
0.00%
0/201
|
2.0%
4/198
|
2.0%
4/201
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place