Trial Outcomes & Findings for CHIZAP: Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumonia (NCT NCT00148733)

Results Overview

Enrolled children will be followed and given zinc or placebo for 14 days. We will compare the proportion with treatment failure (i.e. lack of improvement within 3 days) between the two groups

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

2628 participants

Primary outcome timeframe

Within 2 weeks after enrollment

Results posted on

2022-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Zinc Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months	Placebo Placebo Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
Overall Study STARTED	1314	1314
Overall Study COMPLETED	1300	1299
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CHIZAP: Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zinc n=1314 Participants Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months	Placebo n=1314 Participants Placebo Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months	Total n=2628 Participants Total of all reporting groups
Age, Continuous	7.3 months STANDARD_DEVIATION 7.4 • n=5 Participants	7.2 months STANDARD_DEVIATION 7.2 • n=7 Participants	7.2 months STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	575 Participants n=5 Participants	576 Participants n=7 Participants	1151 Participants n=5 Participants
Sex: Female, Male Male	739 Participants n=5 Participants	738 Participants n=7 Participants	1477 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 2 weeks after enrollment

Enrolled children will be followed and given zinc or placebo for 14 days. We will compare the proportion with treatment failure (i.e. lack of improvement within 3 days) between the two groups

Outcome measures

Outcome measures
Measure	Zinc n=1300 Participants Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months	Placebo n=1299 Participants Placebo Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
Risk of Treatment Failure.	267 participants	253 participants

PRIMARY outcome

Timeframe: Within 2 weeks after enrollment

We will measure to what extent the intervention can reduce the number of severe events.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: six months

We will measure to what extent short term zinc administration has an impact on growth and morbidity for up to 6 months after end of supplementation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: six months

Thymus size will be measured using ultrasonography and compared between the two groups. at two occasions 2.5 and 6 months after end of supplementation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 14 days

Vomiting, regurgitation, pain in abdomen for 15 minutes after zinc or placebo administration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 2 weeks after enrollment

We will also measure of there are factors at baseline that modifies the effect of zinc. Whether the following are modifiers for the above-mentioned effect of zinc given during pneumonia: i.severe inflammation, reflected in: high fever and/or elevated plasma C-reactive protein (CRP) concentration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 2 weeks after enrollment

We will measure to what extent breastfeeding status modifies the effect of zinc on pneumonia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 2 weeks after enrollment

We will compare the efficacy of zinc in those that are stunted, wasted or underweight with those who are not.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

We will compare the efficacy of zinc according to virus detected in nasopharyngeal secretions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

And whether or not these vitamins predict treatment failure and duration of illness.

Outcome measures

Outcome data not reported

Adverse Events

Zinc

Serious events: 0 serious events

Other events: 181 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zinc n=1314 participants at risk Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months	Placebo n=1314 participants at risk Placebo Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
Gastrointestinal disorders Regurgitation	13.8% 181/1314 • 14 days, while zinc or placebo were given Vomiting following zinc or placebo supplementation	4.0% 53/1314 • 14 days, while zinc or placebo were given Vomiting following zinc or placebo supplementation

Additional Information

Tor A Strand

University of Bergen

Phone: 90971086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place