- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03893721
Effect of Chronic Arsenic Exposure on Malnutrition of Under Five Children
Effect of Chronic Arsenic Exposure on Malnutrition Among Under-five Children Attending Assiut University Children Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
prevalence of under-five stunting, wasting and underweight are 21% and , 8% and 6% respectively in Egyptian Demographic Health Survey 2014.
The main risk factors for growth restriction in children are maternal under nutrition during pregnancy, lack of exclusive breastfeeding, inappropriate complementary feeding and micronutrient intake and high prevalence of enteric infections. However, other environmental exposures may also play a role in growth restriction .
High concentrations of Arsenic, lead and cadmium in placenta are associated with poor fetal out come and low birth weight. Arsenic crosses the placenta causing suppression of insulin-Like Growth Factor 1.
When breastfeeding is exclusive, infants are unlikely to be exposed to Arsenic by other routes of exposure such as external foods, drinking water and foods made at home using Arsenic contaminated water.
Rational of the study. Improvement of under-five nutritional status is a global target. Although the exposure to arsenic has increased globally, it's impact on nutritional status has seldom been investigated.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eman Morsy, professor
- Phone Number: 002 01006261140
- Email: emanmma@yahoo.com
Study Contact Backup
- Name: Medhat Araby, assis. prof.
- Phone Number: 002 01000032910
- Email: medhatelaraby75@yahoo.com
Study Locations
-
-
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Assiut, Egypt, 71111
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
female children from 2 to 5 years
Exclusion Criteria:
Severely ill children other than severely malnourished.
- Children with congenital anomaly.
- Relatives.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
malnourished under five children
children from 2 to 5 years with malnutrition
|
analysis of hair samples for Arsenic using Agilent graphite tube atomizer 120
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well nourished under five children
children from 2 to 5 years without malnutrition
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analysis of hair samples for Arsenic using Agilent graphite tube atomizer 120
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic Arsenic Exposure of Under Five Children
Time Frame: one year
|
Hair samples collected from participating children will be analyzed for Arsenic using Agilent graphite tube atomizer (GTA) 120
|
one year
|
weight measurement
Time Frame: one year
|
weight in kilograms will be measured to all participating children
|
one year
|
height measurement
Time Frame: one year
|
height in meters will be measured to all participating children
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alyaa Abdelaal, demonstrator, Assiut University
Publications and helpful links
General Publications
- Walker SP, Wachs TD, Gardner JM, Lozoff B, Wasserman GA, Pollitt E, Carter JA; International Child Development Steering Group. Child development: risk factors for adverse outcomes in developing countries. Lancet. 2007 Jan 13;369(9556):145-57. doi: 10.1016/S0140-6736(07)60076-2.
- Milton AH, Attia J, Alauddin M, McEvoy M, McElduff P, Hussain S, Akhter A, Akter S, Islam MM, Ahmed AMS, Iyengar V, Islam MR. Assessment of Nutritional Status of Infants Living in Arsenic-Contaminated Areas in Bangladesh and Its Association with Arsenic Exposure. Int J Environ Res Public Health. 2018 Jan 2;15(1):57. doi: 10.3390/ijerph15010057.
- Claus Henn B, Ettinger AS, Hopkins MR, Jim R, Amarasiriwardena C, Christiani DC, Coull BA, Bellinger DC, Wright RO. Prenatal Arsenic Exposure and Birth Outcomes among a Population Residing near a Mining-Related Superfund Site. Environ Health Perspect. 2016 Aug;124(8):1308-15. doi: 10.1289/ehp.1510070. Epub 2016 Feb 9.
- Islam MR, Attia J, Alauddin M, McEvoy M, McElduff P, Slater C, Islam MM, Akhter A, d'Este C, Peel R, Akter S, Smith W, Begg S, Milton AH. Availability of arsenic in human milk in women and its correlation with arsenic in urine of breastfed children living in arsenic contaminated areas in Bangladesh. Environ Health. 2014 Dec 4;13:101. doi: 10.1186/1476-069X-13-101.
- Vahter M. Health effects of early life exposure to arsenic. Basic Clin Pharmacol Toxicol. 2008 Feb;102(2):204-11. doi: 10.1111/j.1742-7843.2007.00168.x.
- Signes-Pastor AJ, Cottingham KL, Carey M, Sayarath V, Palys T, Meharg AA, Folt CL, Karagas MR. Infants' dietary arsenic exposure during transition to solid food. Sci Rep. 2018 May 8;8(1):7114. doi: 10.1038/s41598-018-25372-1.
- El-Badry AE-MA, Khalifa MM. Geochemical Assessment of Pollution at Manzala Lake, Egypt: Special Mention to Environmental and Health Effects of Arsenic, Selenium, Tin and Antimony. J Appl Sci [Internet]. 2017;17(2):72-80. Available from: http://dx.doi.org/10.3923/jas.2017.72.80
- El-Badry AE-MA, Khalifa MM. The occurrence and distribution of high-arsenic, selenium, tin and antimony in bottom sediments of Burullus lagoon and its effects on human health, Egypt. J African Earth Sci [Internet]. 2017 Dec 1 [cited 2019 Feb 23];136:305-11. Available from: https://www.sciencedirect.com/science/article/pii/S1464343X17303175?via%3Dihub
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17100702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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