Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia

NCT03355222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2020-11-03

No results posted yet for this study

Summary

Mothers and young children in rural Ethiopia lack sufficient nutrition, and a compounding factor is presence of high levels of fluoride (\> 5-10 mg/day) affecting body functions. Interventions involving chickens to provide eggs and eggshell (a source of calcium) are one solution. The overall purpose is to examine how increasing dietary calcium by using eggshell powder (ESP) reduces fluoride (F) absorption in women. It is known calcium binds F to prevent its absorption but application of this to a community based study has not been tested. The aim is to provide chickens to produce eggs for young children and to provide ESP to women (mothers). For children, an egg a day should improve growth and nutritional status. For women, the ESP provides calcium to reduce fluorosis and therefore improve function without affecting iron and zinc status. For the women, blood samples will be tested in a subsample for F, calcium, zinc and iron; urine samples will be measured for F, calcium and creatinine (to correct spot urine). Hemoglobin will be measured as an indicator of overall nutritional status in women and children. Nutritional status of young children (6-18 mo) and of their mothers prior and after the intervention (by 6 months) will be assessed. between 6 and 12 month there will be monitoring for sustainability of chilckens in the community; for continued use of egg (in children) and ESP (in women); during this time the control group will receive chickens and also undergo monitoring. The study will take place in the Rift valley of Southern Ethiopia. Identification of the knowledge, attitude and practices (KAP) of mothers on egg consumption will be done at baseline and at the end ("endline"). Caregivers will be instructed to give each child 1 egg (cooked) per day in the intervention, and one "bottle cap" of eggshell powder (1000 mg calcium) per day for themselves. Families receiving chickens will be instructed on cage construction. 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 mitigate fluorosis and improve nutritional status.

Conditions

  • Fluoride Poisoning
  • Hemoglobin
  • Underweight
  • Stunting
  • Development; Delayed, Mental
  • Fluorosis, Dental
  • Fluorosis; Skeletal
  • Zinc Deficiency

Interventions

BEHAVIORAL

Promotion of chicken eggs

Community is provided with chickens and young children are to receive one egg a day; selected mothers will consume eggshell.

Sponsors & Collaborators

  • Hawassa University

    collaborator OTHER
  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Susan Whiting, PhD · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2018-12-01
Completion
2019-06-30

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355222 on ClinicalTrials.gov