NCT02791100

Brief Summary

Young children in Ethiopia lack sufficient protein and micronutrients for growth and development. The overall purpose is to assess the effects of promoting egg and eggshell powder consumption on improving the nutritional status of children 6 to 15 months in Halaba Special Woreda, Southern Ethiopia. The hypothesis is that providing chickens to produce eggs (egg and eggshell) for young children will improve growth in otherwise malnourished young children. Upon providing chickens, the nutritional status of young children prior and after the intervention (by 6 months) will be assessed. Identification of the knowledge, attitude and practices (KAP) of mothers on egg and eggshell powder consumption by their children before and after the intervention in the intervention group will be done. Caregivers will be instructed to give each child 1 egg (cooked) and 1/4 "bottle cap" of eggshell (500 mg calcium) per day in the intervention. Hemoglobin will be measured as an indicator of overall nutritional status. Throughout the study, any problems arising in keeping chickens will be recorded in order to assess the feasibility and practicality of raising chickens as way to improve nutritional status of young children. The study is novel in that investigators are providing a way to have increased protein, increased micronutrients, and use of eggshell as a source of calcium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 21, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

May 25, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2016

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

September 21, 2015

Last Update Submit

October 17, 2018

Conditions

Keywords

heightweightdietcomplementary foodsproteincalcium

Outcome Measures

Primary Outcomes (1)

  • weight (kg)

    weight (kg) of child

    6 months

Secondary Outcomes (3)

  • knowledge, attitudes and practices on egg and egg shell use via questionnaire

    6 months

  • health status as hemoglobin measure

    6 months

  • incidence of reported infections in study children

    6 months

Study Arms (2)

No promotion of chicken eggs

NO INTERVENTION

The community receives no chickens and therefore has no additional eggs or egg shell powder for children

Promotion of Chicken eggs for children

EXPERIMENTAL

The community receives chickens so that each study child receives 2 eggs a day and also receives some egg shell daily (1/4 bottle cap which provides 500 mg Ca). The community receives information on using the egg and eggshell, and has help in caring for the chickens.

Behavioral: Promotion of chicken eggs

Interventions

Community is provided with chickens and young children are to receive 2 eggs a day plus egg shell

Promotion of Chicken eggs for children

Eligibility Criteria

Age6 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • not known to be allergic to eggs.
  • not undergoing therapy for moderate or severe malnutrition.

You may not qualify if:

  • children undergoing treatment for malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawassa University School of Nutrition, Food Science

Awasa, Ethiopia

Location

Related Publications (5)

  • Brun LR, Lupo M, Delorenzi DA, Di Loreto VE, Rigalli A. Chicken eggshell as suitable calcium source at home. Int J Food Sci Nutr. 2013 Sep;64(6):740-3. doi: 10.3109/09637486.2013.787399. Epub 2013 Apr 22.

    PMID: 23607686BACKGROUND
  • Mukaratirwa S, Khumalo MP. Prevalence of helminth parasites in free-range chickens from selected rural communities in KwaZulu-Natal province of South Africa. J S Afr Vet Assoc. 2010 Jun;81(2):97-101. doi: 10.4102/jsava.v81i2.113.

    PMID: 21247015BACKGROUND
  • Victora CG, de Onis M, Hallal PC, Blossner M, Shrimpton R. Worldwide timing of growth faltering: revisiting implications for interventions. Pediatrics. 2010 Mar;125(3):e473-80. doi: 10.1542/peds.2009-1519. Epub 2010 Feb 15.

    PMID: 20156903BACKGROUND
  • Negash C, Belachew T, Henry CJ, Kebebu A, Abegaz K, Whiting SJ. Nutrition education and introduction of broad bean-based complementary food improves knowledge and dietary practices of caregivers and nutritional status of their young children in Hula, Ethiopia. Food Nutr Bull. 2014 Dec;35(4):480-6. doi: 10.1177/156482651403500409.

    PMID: 25639132BACKGROUND
  • Omer A, Mulualem D, Classen H, Vatanparast H, Whiting SJ (2018) Promotion of Egg and Eggshell Powder Consumption Improves Nutritional Status of Children of Under Two Years of Age: A Cluster Randomized Controlled Community Trial in Halaba Sp. Woreda, SNNPR Journal of Agricultural Science, 10(5), ISSN 1916-9752 E-ISSN 1916-9760.

    RESULT

MeSH Terms

Conditions

ThinnessFeeding BehaviorBehaviorBody Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior, Animal

Study Officials

  • Susan J Whiting, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

September 21, 2015

First Posted

June 6, 2016

Study Start

May 25, 2016

Primary Completion

December 22, 2016

Study Completion

December 22, 2016

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Only group data, means, median

Locations