A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose

OBJECTIVE: To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea. METHODS: One hundred ninety boys, ages 1 to 24 months, who were admit...

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Veröffentlicht in:The Journal of pediatrics 1996, Vol.128 (1), p.45-51
Hauptverfasser: Santosham, Mathuram, Fayad, Ibrahim, Zikri, Maha Abu, Hussein, Abeer, Amponsah, Akwasi, Duggan, Christopher, Hashem, Mohamed, Sady, Nermine El, Zikri, Mona Abu, Fontaine, Olivier
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container_end_page 51
container_issue 1
container_start_page 45
container_title The Journal of pediatrics
container_volume 128
creator Santosham, Mathuram
Fayad, Ibrahim
Zikri, Maha Abu
Hussein, Abeer
Amponsah, Akwasi
Duggan, Christopher
Hashem, Mohamed
Sady, Nermine El
Zikri, Mona Abu
Fontaine, Olivier
description OBJECTIVE: To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea. METHODS: One hundred ninety boys, ages 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours. RESULTS: In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 ± 6 mEq/L) than in children receiving the standard WHO ORS (138 ± 7 mEq/L) ( p
doi_str_mv 10.1016/S0022-3476(96)70426-2
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METHODS: One hundred ninety boys, ages 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours. RESULTS: In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 ± 6 mEq/L) than in children receiving the standard WHO ORS (138 ± 7 mEq/L) ( p &lt;0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups. CONCLUSION: The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea. (J P EDIATR 1996;128:45-51)</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/S0022-3476(96)70426-2</identifier><identifier>PMID: 8551420</identifier><identifier>CODEN: JOPDAB</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Acute Disease ; Biological and medical sciences ; Diarrhea, Infantile - therapy ; Double-Blind Method ; Egypt ; Fluid Therapy - methods ; Glucose - analysis ; Humans ; Infant ; Male ; Medical sciences ; Miscellaneous ; Osmolar Concentration ; Population ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Rehydration Solutions - chemistry ; Rehydration Solutions - therapeutic use ; Risk ; Sodium - analysis ; Treatment Outcome ; Tropical medicine ; World Health Organization</subject><ispartof>The Journal of pediatrics, 1996, Vol.128 (1), p.45-51</ispartof><rights>1996 Mosby, Inc.</rights><rights>1996 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-fcf293cce696e02a67a07d5d494432b55b155237c44063870848c8ec75b32aed3</citedby><cites>FETCH-LOGICAL-c436t-fcf293cce696e02a67a07d5d494432b55b155237c44063870848c8ec75b32aed3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0022347696704262$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27900,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=2962581$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8551420$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Santosham, Mathuram</creatorcontrib><creatorcontrib>Fayad, Ibrahim</creatorcontrib><creatorcontrib>Zikri, Maha Abu</creatorcontrib><creatorcontrib>Hussein, Abeer</creatorcontrib><creatorcontrib>Amponsah, Akwasi</creatorcontrib><creatorcontrib>Duggan, Christopher</creatorcontrib><creatorcontrib>Hashem, Mohamed</creatorcontrib><creatorcontrib>Sady, Nermine El</creatorcontrib><creatorcontrib>Zikri, Mona Abu</creatorcontrib><creatorcontrib>Fontaine, Olivier</creatorcontrib><title>A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>OBJECTIVE: To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea. METHODS: One hundred ninety boys, ages 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours. RESULTS: In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 ± 6 mEq/L) than in children receiving the standard WHO ORS (138 ± 7 mEq/L) ( p &lt;0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups. CONCLUSION: The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea. (J P EDIATR 1996;128:45-51)</description><subject>Acute Disease</subject><subject>Biological and medical sciences</subject><subject>Diarrhea, Infantile - therapy</subject><subject>Double-Blind Method</subject><subject>Egypt</subject><subject>Fluid Therapy - methods</subject><subject>Glucose - analysis</subject><subject>Humans</subject><subject>Infant</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Miscellaneous</subject><subject>Osmolar Concentration</subject><subject>Population</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Rehydration Solutions - chemistry</subject><subject>Rehydration Solutions - therapeutic use</subject><subject>Risk</subject><subject>Sodium - analysis</subject><subject>Treatment Outcome</subject><subject>Tropical medicine</subject><subject>World Health Organization</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc9u1DAQxi1EVZbCI1TyASE4pDj-m5xQVQFFqtQDII6WY0-2Rk68tWPQ8k68Y93d1XLsZWzN_Oab0XwInbfkoiWt_PCNEEobxpV818v3inAqG_oMrVrSq0Z2jD1HqyPyAr3M-RchpOeEnKLTToiWU7JC_y6xi2UI0AzBzw7bGr01AS_J12jjtDHJz2v8M6bg8DWYsNzh27Q2s_9rFh9nHFMFE9xtXdoncgxl9_njK2tqzRULDsc8xVDVlu1_xMZ5MXVknQD3pQqZKZZ5yTiOFXK-TNjUtdah2JjhFToZTcjw-vCeoR-fP32_um5ubr98vbq8aSxncmlGO9KeWQuyl0CokcoQ5YTjPeeMDkIMrRCUKcs5kaxTpOOd7cAqMTBqwLEz9Havu0nxvkBe9OSzhRDMDLFkrVQvO8lFBcUetCnmnGDUm-Qnk7a6JfrRJr2zST96oHupdzZpWvvODwPKMIE7dh18qfU3h7rJ1Y0xmdn6fMRoL6no2op93GNQj_HbQ9LZepjrsX0Cu2gX_ROLPAB4SrLv</recordid><startdate>1996</startdate><enddate>1996</enddate><creator>Santosham, Mathuram</creator><creator>Fayad, Ibrahim</creator><creator>Zikri, Maha Abu</creator><creator>Hussein, Abeer</creator><creator>Amponsah, Akwasi</creator><creator>Duggan, Christopher</creator><creator>Hashem, Mohamed</creator><creator>Sady, Nermine El</creator><creator>Zikri, Mona Abu</creator><creator>Fontaine, Olivier</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>1996</creationdate><title>A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose</title><author>Santosham, Mathuram ; Fayad, Ibrahim ; Zikri, Maha Abu ; Hussein, Abeer ; Amponsah, Akwasi ; Duggan, Christopher ; Hashem, Mohamed ; Sady, Nermine El ; Zikri, Mona Abu ; Fontaine, Olivier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c436t-fcf293cce696e02a67a07d5d494432b55b155237c44063870848c8ec75b32aed3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1996</creationdate><topic>Acute Disease</topic><topic>Biological and medical sciences</topic><topic>Diarrhea, Infantile - therapy</topic><topic>Double-Blind Method</topic><topic>Egypt</topic><topic>Fluid Therapy - methods</topic><topic>Glucose - analysis</topic><topic>Humans</topic><topic>Infant</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Miscellaneous</topic><topic>Osmolar Concentration</topic><topic>Population</topic><topic>Radiotherapy. 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METHODS: One hundred ninety boys, ages 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours. RESULTS: In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 ± 6 mEq/L) than in children receiving the standard WHO ORS (138 ± 7 mEq/L) ( p &lt;0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups. CONCLUSION: The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea. (J P EDIATR 1996;128:45-51)</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>8551420</pmid><doi>10.1016/S0022-3476(96)70426-2</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Acute Disease
Biological and medical sciences
Diarrhea, Infantile - therapy
Double-Blind Method
Egypt
Fluid Therapy - methods
Glucose - analysis
Humans
Infant
Male
Medical sciences
Miscellaneous
Osmolar Concentration
Population
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Rehydration Solutions - chemistry
Rehydration Solutions - therapeutic use
Risk
Sodium - analysis
Treatment Outcome
Tropical medicine
World Health Organization
title A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose
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