CClinicalTrials.gg
Status unknownNCT03893721Updated Mar 28, 2019

Effect of Chronic Arsenic Exposure on Malnutrition of Under Five Children

An observational study in Malnutrition, Child and Arsenic Poisoning Chronic, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
2 Years to 5 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Malnutrition, Child
  • Arsenic Poisoning Chronic
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's planned enrollment of 80 is below the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

under five children attending Assiut university Children Hospital

Inclusion criteria

female children from 2 to 5 years

Exclusion criteria

Exclusion Criteria:

Severely ill children other than severely malnourished.

  • Children with congenital anomaly.
  • Relatives.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • malnourished under five children

    children from 2 to 5 years with malnutrition

    Diagnostic Test: arsenic exposure

  • well nourished under five children

    children from 2 to 5 years without malnutrition

    Diagnostic Test: arsenic exposure

Interventions

  • Diagnostic testarsenic exposure

    analysis of hair samples for Arsenic using Agilent graphite tube atomizer 120

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

  2. weight measurement

    weight in kilograms will be measured to all participating children

    Time frame: one year

  3. height measurement

    height in meters will be measured to all participating children

    Time frame: one year

07

Study locations

1 site
  • Assiut University
    Assiut, 71111, Egypt
08

References and documents

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. PubMed 17223478 ↗
  • 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. PubMed 29301293 ↗
  • 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. PubMed 26859631 ↗
  • 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. PubMed 25471535 ↗
  • 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. PubMed 18226075 ↗
  • 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. PubMed 29739998 ↗
  • 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

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03893721
Lead sponsor
Assiut University
Responsible party
alyaa abdelaal mohamed abdelaal (principle investigator, Assiut University) — Principal investigator
First posted
Mar 28, 2019
Start date
Jun 2019 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Jun 2020 (estimated)
Last update
Mar 28, 2019

Study contacts

Eman Morsy, professor
Contact
emanmma@yahoo.com
01006261140 ext. 002
Medhat Araby, assis. prof.
Contact
medhatelaraby75@yahoo.com
01000032910 ext. 002
Alyaa Abdelaal, demonstrator
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion