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| Name | Class |
|---|---|
| UNICEF | OTHER |
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This study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. One study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that investigators will use as control.
In Mexico acute diarrheal diseases mortality in children continues to be a public health issue, being between the main causes of morbidity and mortality, with an important load for the health systems. Consequently, there exists a necessity for the implementation of alternate strategies for this condition, nutrition being one of the pillars to strengthen.
Zinc administration during the diarrhea episode is a simple intervention for clinical picture reduction and relapse. The recommendation of including zinc in the treatment of ADD is not part of the Mexican normativity. The evaluation of the efficacy of zinc administration in Mexican children is insufficient and a program or national strategy for zinc treatment does not exist.
The objective of this study is evaluates the efficacy of oral zinc sulfate administration, during the diarrhea clinic picture in children of Mexico City.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc sulfate | Experimental | Zinc sulfate 20 mg by mouth, once a day for 10 days |
|
| Placebo | Placebo Comparator | Placebo tablet, once a day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc sulfate | Dietary Supplement | zinc 20mg tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Diarrhea duration | Number of hours from the inclusion of the patient until the end of the diarrhea. The end of diarrhea was defined as the last diarrhea evacuation followed by a 48 hr period without diarrhea | 10 days |
| Stool frequency | Number of stools during during the acute diarrheic disease | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| diarrheic disease recurrence | Number of acute diarrheal episode, after the first episode | 3 and 6 months |
| zinc serum concentration | Difference of zinc serum concentration after the oral treatment for 10 days with 20 mg of zinc, and its correlation with the duration of diarrhea , the number of total stools and relapse rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Salmeron, PHD | Universidad Nacional Autonoma de Mexico | Study Chair |
| Edgar Sanchez, McS | Universidad Nacional Autonoma de Mexico | Study Director |
| Marcelino Esparza Aguilar, PhD | National Institute of Pediatrics in Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pediatrico de Coyoacan | Mexico City | 04000 | Mexico | |||
| Instituto Nacional de Pediatria |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 22, 2017 | Aug 2, 2019 |
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| Dietary Supplement |
Sugar pill manufactured to mimic zinc 20mg tablet |
|
|
| 3, 9, 20, 31, 61, 91 and 121 days |
| Mexico City |
| 04530 |
| Mexico |
| Hospital Pediatrico La Villa | Mexico City | 07050 | Mexico |
| Hospital Pediatrico de Iztapalapa | Mexico City | 09070 | Mexico |
| Hospital Pediátrico de Tacubaya | Mexico City | 11870 | Mexico |
| Centro de Salud Cultura Maya | Mexico City | 14230 | Mexico |
| Centro de Salud San Andres Totoltepec | Mexico City | 14400 | Mexico |
| Centro de Salud Topilejo | Mexico City | 14500 | Mexico |
| Hospital Materno Infantil de Xochimilco | Mexico City | 16090 | Mexico |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2017 | Aug 15, 2019 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003968 | Diarrhea, Infantile |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |
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