Trial Outcomes & Findings for Micronutrient Sprinkles in a Daycare Center (NCT NCT00967551)

Results Overview

Number of children with diarrhea divided by the number of children in the group

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

143 participants

Primary outcome timeframe

6 months

Results posted on

2013-04-11

Participant Flow

Healthy, 06 to 48 months old children attending a day care. They were randomized into two groups and received daily zinc micronutrient + - test group (sprinkles) or without zinc micronutrient only - control. Children were supplemented for 90 days

Participant milestones

Participant milestones
Measure	Micronutrient Sprinkles Without Zinc Micronutrient sprinkles without zinc Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc	Micronutrient Sprinkles With Zinc Micronutrient sprinkles with zinc gluconate Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles
Overall Study STARTED	68	75
Overall Study COMPLETED	68	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Micronutrient Sprinkles in a Daycare Center

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Micronutrient Sprinkles Without Zinc n=68 Participants Micronutrient sprinkles without zinc Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc	Micronutrient Sprinkles With Zinc n=75 Participants Micronutrient sprinkles with zinc gluconate Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles	Total n=143 Participants Total of all reporting groups
Age, Categorical <=18 years	68 Participants n=93 Participants	75 Participants n=4 Participants	143 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	2.1 years STANDARD_DEVIATION 2 • n=93 Participants	2.2 years STANDARD_DEVIATION 2 • n=4 Participants	2.1 years STANDARD_DEVIATION 2 • n=27 Participants
Sex: Female, Male Female	33 Participants n=93 Participants	27 Participants n=4 Participants	60 Participants n=27 Participants
Sex: Female, Male Male	35 Participants n=93 Participants	48 Participants n=4 Participants	83 Participants n=27 Participants
Region of Enrollment Brazil	68 participants n=93 Participants	75 participants n=4 Participants	143 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All children enrolled

Number of children with diarrhea divided by the number of children in the group

Outcome measures

Outcome measures
Measure	Micronutrient Sprinkles Without Zinc n=68 Participants Micronutrient sprinkles without zinc Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc	Micronutrient Sprinkles With Zinc n=75 Participants Micronutrient sprinkles with zinc gluconate Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles
Proportion of Children of Diarrhea Episodes	19.1 percentage of participants	14.7 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: All children enrolled

Number of children with respiratory infections divided by the total number of children in the group

Outcome measures

Outcome measures
Measure	Micronutrient Sprinkles Without Zinc n=68 Participants Micronutrient sprinkles without zinc Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc	Micronutrient Sprinkles With Zinc n=75 Participants Micronutrient sprinkles with zinc gluconate Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles
Proportion of Children With Respiratory Infections	48.5 percentage of participants	60 percentage of participants

Adverse Events

Micronutrient Sprinkles Without Zinc

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Micronutrient Sprinkles With Zinc

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

Hugo Costa-Ribeiro

Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brasil

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place