NCT03893721

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 22, 2019

Last Update Submit

March 26, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • weight measurement

    weight in kilograms will be measured to all participating children

    one year

  • height measurement

    height in meters will be measured to all participating children

    one year

Study Arms (2)

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

arsenic exposureDIAGNOSTIC_TEST

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

malnourished under five childrenwell nourished under five children

Eligibility Criteria

Age2 Years - 5 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

under five children attending Assiut university Children Hospital

You may qualify if:

  • female children from 2 to 5 years

You may not qualify if:

  • Severely ill children other than severely malnourished.
  • Children with congenital anomaly.
  • Relatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 17223478BACKGROUND
  • 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.

    PMID: 29301293BACKGROUND
  • 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.

    PMID: 26859631BACKGROUND
  • 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.

    PMID: 25471535BACKGROUND
  • 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.

    PMID: 18226075BACKGROUND
  • 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.

    PMID: 29739998BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair samples

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Alyaa Abdelaal, demonstrator

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Morsy, professor

CONTACT

Medhat Araby, assis. prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 28, 2019

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations