Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03893721
Other study ID # 17100702
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2019
Est. completion date June 2020

Study information

Verified date March 2019
Source Assiut University
Contact Eman Morsy, professor
Phone 01006261140
Email emanmma@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Early life malnutrition is associated with later life health problems, Particularly Stunting, which is a height-for-age Z score less than -2 standard deviation of World Health Organization median.Underweight is weight-for-age Z score less than -2 standard deviation of World Health Organization median. Wasting is weight -for- height Z score less than -2 standard deviation of World Health Organization median.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date June 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 2 Years to 5 Years
Eligibility Inclusion Criteria:

female children from 2 to 5 years

Exclusion Criteria:

Severely ill children other than severely malnourished.

- Children with congenital anomaly.

- Relatives.

Study Design


Intervention

Diagnostic Test:
arsenic exposure
analysis of hair samples for Arsenic using Agilent graphite tube atomizer 120

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View Citation

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

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. — View Citation

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). pii: E57. doi: 10.3390/ijerph15010057. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic Arsenic Exposure of Under Five Children Hair samples collected from participating children will be analyzed for Arsenic using Agilent graphite tube atomizer (GTA) 120 one year
Primary weight measurement weight in kilograms will be measured to all participating children one year
Primary height measurement height in meters will be measured to all participating children one year
See also
  Status Clinical Trial Phase
Completed NCT05012592 - Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses N/A
Completed NCT04216043 - Milk Matters in Malnutrition, is it the Lactose or Dairy Protein? N/A
Enrolling by invitation NCT05603793 - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
Completed NCT03573713 - Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes N/A
Not yet recruiting NCT05792514 - The Reliable Nutritional Risk Screening Tools
Recruiting NCT04109352 - Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy
Enrolling by invitation NCT03355313 - Use of Low-level Laser Therapy on Children Aged One to Five Years With Energy-protein Malnutrition N/A
Completed NCT05551819 - Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition N/A
Completed NCT04101487 - Cash Transfers to Increase Dietary Diversity in Grand Gedeh County, Liberia N/A
Active, not recruiting NCT05571280 - Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene. N/A
Withdrawn NCT05437068 - Nutritional Supplementation in Children at Risk of Undernutrition N/A
Recruiting NCT05442424 - Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii N/A
Completed NCT03454100 - Community Resilience to Acute Malnutrition N/A
Completed NCT04896996 - The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY) N/A
Not yet recruiting NCT06049680 - Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients Phase 4
Recruiting NCT06382857 - Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition N/A
Recruiting NCT05269992 - Childrens Real Food Tolerance Study N/A
Active, not recruiting NCT05123378 - Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality N/A
Completed NCT04688515 - Effectiveness of a Positive Deviance Program in Reducing Childhood Undernutrition N/A
Not yet recruiting NCT04810468 - Study of Malnutrition in Primary School Children N/A

External Links