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| Name | Class |
|---|---|
| Federal University of Bahia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronutrient Sprinkles without zinc | Active Comparator | Micronutrient sprinkles without zinc |
|
| Micronutrient sprinkles with zinc | Experimental | Micronutrient sprinkles with zinc gluconate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronutrient Sprinkles with zinc | Dietary Supplement | Daily dose of 1 packet of sprinkles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Children of Diarrhea Episodes | Number of children with diarrhea divided by the number of children in the group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Children With Respiratory Infections | Number of children with respiratory infections divided by the total number of children in the group | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conrad R Cole, MD, MPH, MSc | Emory University | Principal Investigator |
| Hugo Ribeiro Da Costa, MD, PhD | Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz, Salvador, Bahia, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz | Salvador | Estado de Bahia | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36994923 | Derived | Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Micronutrient Sprinkles Without Zinc | Micronutrient sprinkles without zinc Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc |
| FG001 | Micronutrient Sprinkles With Zinc | Micronutrient sprinkles with zinc gluconate Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Micronutrient Sprinkles Without Zinc | Micronutrient sprinkles without zinc Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc |
| BG001 | Micronutrient Sprinkles With Zinc |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Children of Diarrhea Episodes | Number of children with diarrhea divided by the number of children in the group | All children enrolled | Posted | Number | percentage of participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micronutrient Sprinkles Without Zinc | Micronutrient sprinkles without zinc Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hugo Costa-Ribeiro | Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brasil | hugocrj@ufba.br |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Micronutrient sprinkles without zinc | Dietary Supplement | I packet of micronutrient sprinkles without zinc |
|
|
Micronutrient sprinkles with zinc gluconate
Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Proportion of Children With Respiratory Infections | Number of children with respiratory infections divided by the total number of children in the group | All children enrolled | Posted | Number | percentage of participants | 6 months |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Micronutrient Sprinkles With Zinc | Micronutrient sprinkles with zinc gluconate Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles | 0 | 75 | 0 | 75 |
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| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D008670 |
| Metals |