Diarrhea, Respiratory Infection
Conditions
Keywords
Diarrhea, Pneumonia, Upper respiratory infections, Acute gastroenteritis
Brief summary
Diarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of micronutrient deficiencies including zinc. The primary aims of the proposed study are to evaluate the effect of the use of multiple micronutrient sprinkles including zinc on compliance of supplement use and the incidence of recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.
Detailed description
The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.
Interventions
DIETARY_SUPPLEMENTMicronutrient Sprinkles with zinc
Daily dose of 1 packet of sprinkles
DIETARY_SUPPLEMENTMicronutrient sprinkles without zinc
I packet of micronutrient sprinkles without zinc
Sponsors
Federal University of Bahia
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy children attending day care
Exclusion criteria
* Chronic medical problems including sickle cell disease, congenital heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Children of Diarrhea Episodes | 6 months | Number of children with diarrhea divided by the number of children in the group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Children With Respiratory Infections | 6 months | Number of children with respiratory infections divided by the total number of children in the group |
Countries
Brazil
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Micronutrient Sprinkles Without Zinc Micronutrient sprinkles without zinc
Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc | 68 |
| Micronutrient Sprinkles With Zinc Micronutrient sprinkles with zinc gluconate
Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles | 75 |
| Total | 143 |
Baseline characteristics
| Characteristic | Micronutrient Sprinkles With Zinc | Micronutrient Sprinkles Without Zinc | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 75 Participants | 68 Participants | 143 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 2.2 years STANDARD_DEVIATION 2 | 2.1 years STANDARD_DEVIATION 2 | 2.1 years STANDARD_DEVIATION 2 |
| Region of Enrollment Brazil | 75 participants | 68 participants | 143 participants |
| Sex: Female, Male Female | 27 Participants | 33 Participants | 60 Participants |
| Sex: Female, Male Male | 48 Participants | 35 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 75 |
| serious Total, serious adverse events | 0 / 68 | 0 / 75 |
Outcome results
Primary
Proportion of Children of Diarrhea Episodes
Number of children with diarrhea divided by the number of children in the group
Time frame: 6 months
Population: All children enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micronutrient Sprinkles Without Zinc | Proportion of Children of Diarrhea Episodes | 19.1 percentage of participants |
| Micronutrient Sprinkles With Zinc | Proportion of Children of Diarrhea Episodes | 14.7 percentage of participants |
Secondary
Proportion of Children With Respiratory Infections
Number of children with respiratory infections divided by the total number of children in the group
Time frame: 6 months
Population: All children enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micronutrient Sprinkles Without Zinc | Proportion of Children With Respiratory Infections | 48.5 percentage of participants |
| Micronutrient Sprinkles With Zinc | Proportion of Children With Respiratory Infections | 60 percentage of participants |