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The Effect of Deworming on Growth in One-Year-Old Children Living in a Soil-Transmitted Helminth-Endemic Area of Peru: A Randomized Controlled Trial.

Joseph SA, Casapía M, Montresor A, Rahme E, Ward BJ, Marquis GS, Pezo L, Blouin B, Maheu-Giroux M, Gyorkos TW - PLoS Negl Trop Dis (2015)

Bottom Line: One such intervention may include population-based deworming, recommended as of 12 months of age by the World Health Organization in soil-transmitted helminth (STH)-endemic areas; however, the benefit of deworming has been understudied in early preschool-age children.There was no statistically significant difference in weight gain in any of the deworming intervention groups compared to the control group.Overall, with one year of follow-up, no effect of deworming on growth could be detected in this population of preschool-age children.

View Article: PubMed Central - PubMed

Affiliation: McGill University, Department of Epidemiology, Biostatistics and Occupational Health, Montréal, Québec, Canada; Research Institute of the McGill University Health Centre, Division of Clinical Epidemiology, Montréal, Québec, Canada.

ABSTRACT

Background: Appropriate health and nutrition interventions to prevent long-term adverse effects in children are necessary before two years of age. One such intervention may include population-based deworming, recommended as of 12 months of age by the World Health Organization in soil-transmitted helminth (STH)-endemic areas; however, the benefit of deworming has been understudied in early preschool-age children.

Methodology/principal findings: A randomized, double-blind, placebo-controlled trial was conducted to determine the effect of deworming (500 mg single-dose crushed mebendazole tablet) on growth in one-year-old children in Iquitos, Peru. Children were enrolled during their routine 12-month growth and development clinic visit and followed up at their 18 and 24-month visits. Children were randomly allocated to: Group 1: deworming at 12 months and placebo at 18 months; Group 2: placebo at 12 months and deworming at 18 months; Group 3: deworming at both 12 and 18 months; or Group 4: placebo at both 12 and 18 months (i.e. control group). The primary outcome was weight gain at the 24-month visit. An intention-to-treat approach was used. A total of 1760 children were enrolled between September 2011 and June 2012. Follow-up of 1563 children (88.8%) was completed by July 2013. STH infection was of low prevalence and predominantly light intensity in the study population. All groups gained between 1.93 and 2.05 kg on average over 12 months; the average difference in weight gain (kg) compared to placebo was: 0.05 (95% CI: -0.05, 0.17) in Group 1; -0.07 (95%CI: -0.17, 0.04) in Group 2; and 0.04 (95%CI: -0.06, 0.14) in Group 3. There was no statistically significant difference in weight gain in any of the deworming intervention groups compared to the control group.

Conclusions: Overall, with one year of follow-up, no effect of deworming on growth could be detected in this population of preschool-age children. Low baseline STH prevalence and intensity and/or access to deworming drugs outside of the trial may have diluted the potential effect of the intervention. Additional research is required to overcome these challenges and to contribute to strengthening the evidence base on deworming.

Trial registration: ClinicalTrials.gov (NCT01314937).

No MeSH data available.


Related in: MedlinePlus

Trial profile.*26 participants were screened but were not enrolled once the sample size was met. **1 Group 1 (MBD/PBO) = mebendazole (12 months)/placebo (18 months); 2 Group 2 (PBO/MBD) = placebo (12 months)/mebendazole (18 months); 3 Group 3 (MBD/MBD) = mebendazole (12 months)/mebendazole (18 months); 4 Group 4 (PBO/PBO) = placebo (12 months)/placebo (18 months).
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pntd.0004020.g001: Trial profile.*26 participants were screened but were not enrolled once the sample size was met. **1 Group 1 (MBD/PBO) = mebendazole (12 months)/placebo (18 months); 2 Group 2 (PBO/MBD) = placebo (12 months)/mebendazole (18 months); 3 Group 3 (MBD/MBD) = mebendazole (12 months)/mebendazole (18 months); 4 Group 4 (PBO/PBO) = placebo (12 months)/placebo (18 months).

Mentions: Between September 2011 and June 2012, the parents of 2297 children were approached to participate in the trial. Five-hundred and thirty-seven children were excluded as they did not meet the inclusion criteria (n = 385), declined to participate (n = 126), or were approached but not enrolled once the sample size was reached (n = 26). A total of 1760 children were randomized to the four groups (Fig 1). All children received the assigned intervention at baseline. A total of 1606 children (91.2%) attended their first follow-up at the 18-month visit between March 2012 and January 2013. Due to parental refusal, three children did not receive their randomly allocated intervention. The average time between the baseline and first follow-up visit was 6.3 months (± 0.41) and between the first follow-up visit and the second follow-up visit was 6.3 months (± 0.47). The average time between the baseline and second follow-up visit was 12.6 months (± 0.67). Time between visits was equivalent among intervention groups. The second follow-up visit was completed between September 2012 and July 2013.


The Effect of Deworming on Growth in One-Year-Old Children Living in a Soil-Transmitted Helminth-Endemic Area of Peru: A Randomized Controlled Trial.

Joseph SA, Casapía M, Montresor A, Rahme E, Ward BJ, Marquis GS, Pezo L, Blouin B, Maheu-Giroux M, Gyorkos TW - PLoS Negl Trop Dis (2015)

Trial profile.*26 participants were screened but were not enrolled once the sample size was met. **1 Group 1 (MBD/PBO) = mebendazole (12 months)/placebo (18 months); 2 Group 2 (PBO/MBD) = placebo (12 months)/mebendazole (18 months); 3 Group 3 (MBD/MBD) = mebendazole (12 months)/mebendazole (18 months); 4 Group 4 (PBO/PBO) = placebo (12 months)/placebo (18 months).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4591279&req=5

pntd.0004020.g001: Trial profile.*26 participants were screened but were not enrolled once the sample size was met. **1 Group 1 (MBD/PBO) = mebendazole (12 months)/placebo (18 months); 2 Group 2 (PBO/MBD) = placebo (12 months)/mebendazole (18 months); 3 Group 3 (MBD/MBD) = mebendazole (12 months)/mebendazole (18 months); 4 Group 4 (PBO/PBO) = placebo (12 months)/placebo (18 months).
Mentions: Between September 2011 and June 2012, the parents of 2297 children were approached to participate in the trial. Five-hundred and thirty-seven children were excluded as they did not meet the inclusion criteria (n = 385), declined to participate (n = 126), or were approached but not enrolled once the sample size was reached (n = 26). A total of 1760 children were randomized to the four groups (Fig 1). All children received the assigned intervention at baseline. A total of 1606 children (91.2%) attended their first follow-up at the 18-month visit between March 2012 and January 2013. Due to parental refusal, three children did not receive their randomly allocated intervention. The average time between the baseline and first follow-up visit was 6.3 months (± 0.41) and between the first follow-up visit and the second follow-up visit was 6.3 months (± 0.47). The average time between the baseline and second follow-up visit was 12.6 months (± 0.67). Time between visits was equivalent among intervention groups. The second follow-up visit was completed between September 2012 and July 2013.

Bottom Line: One such intervention may include population-based deworming, recommended as of 12 months of age by the World Health Organization in soil-transmitted helminth (STH)-endemic areas; however, the benefit of deworming has been understudied in early preschool-age children.There was no statistically significant difference in weight gain in any of the deworming intervention groups compared to the control group.Overall, with one year of follow-up, no effect of deworming on growth could be detected in this population of preschool-age children.

View Article: PubMed Central - PubMed

Affiliation: McGill University, Department of Epidemiology, Biostatistics and Occupational Health, Montréal, Québec, Canada; Research Institute of the McGill University Health Centre, Division of Clinical Epidemiology, Montréal, Québec, Canada.

ABSTRACT

Background: Appropriate health and nutrition interventions to prevent long-term adverse effects in children are necessary before two years of age. One such intervention may include population-based deworming, recommended as of 12 months of age by the World Health Organization in soil-transmitted helminth (STH)-endemic areas; however, the benefit of deworming has been understudied in early preschool-age children.

Methodology/principal findings: A randomized, double-blind, placebo-controlled trial was conducted to determine the effect of deworming (500 mg single-dose crushed mebendazole tablet) on growth in one-year-old children in Iquitos, Peru. Children were enrolled during their routine 12-month growth and development clinic visit and followed up at their 18 and 24-month visits. Children were randomly allocated to: Group 1: deworming at 12 months and placebo at 18 months; Group 2: placebo at 12 months and deworming at 18 months; Group 3: deworming at both 12 and 18 months; or Group 4: placebo at both 12 and 18 months (i.e. control group). The primary outcome was weight gain at the 24-month visit. An intention-to-treat approach was used. A total of 1760 children were enrolled between September 2011 and June 2012. Follow-up of 1563 children (88.8%) was completed by July 2013. STH infection was of low prevalence and predominantly light intensity in the study population. All groups gained between 1.93 and 2.05 kg on average over 12 months; the average difference in weight gain (kg) compared to placebo was: 0.05 (95% CI: -0.05, 0.17) in Group 1; -0.07 (95%CI: -0.17, 0.04) in Group 2; and 0.04 (95%CI: -0.06, 0.14) in Group 3. There was no statistically significant difference in weight gain in any of the deworming intervention groups compared to the control group.

Conclusions: Overall, with one year of follow-up, no effect of deworming on growth could be detected in this population of preschool-age children. Low baseline STH prevalence and intensity and/or access to deworming drugs outside of the trial may have diluted the potential effect of the intervention. Additional research is required to overcome these challenges and to contribute to strengthening the evidence base on deworming.

Trial registration: ClinicalTrials.gov (NCT01314937).

No MeSH data available.


Related in: MedlinePlus