Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia

NCT03355222 | Completed

• 1 other identifier: HU-UoS-EGGSHELL-FLUORIDE
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

complementary feeding; calcium

Outcome Measures

Primary Outcomes (1)

• Apparent fluoride absorption

  Change in urinary fluoride corrected for creatinine as a measure of F absorption

  6 months

Secondary Outcomes (5)

• Growth in young children

  6 months and 12 months

• Functional indicators of fluorosis

  6 months

• Hemoglobin (Hb)

  6 months and 12 months

• Knowledge, attitude and practices (KAP) for egg

  6 and 12 months

• Linear growth in young children

  6 months and 12 months

Other Outcomes (1)

• Inhibition of zinc absorption

  6 months

Study Arms (2)

No Intervention

NO INTERVENTION

No intervention: The community receives no chickens and no special education is provided.

Experimental: providing chickens and egg shell

EXPERIMENTAL

Experimental: Two chickens are given to each family so that eggs are available for children and of eggshell powder for mothers. The community receives these chickens so each designated family has an egg to give to young child. In a subgroup the mother will receive ESP (1000 mg calcium). The community receives information on using egg and has help on caring for chickens.

Behavioral: Promotion of chicken eggs

Interventions

Promotion of chicken eggs BEHAVIORAL

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

Experimental: providing chickens and egg shell

Eligibility Criteria

• Age: 6 Months - 18 Months
• Gender Eligibility Details: Children will be male and female but "mothers" will only be female.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All women with a child age 6 to 18 months and their child living permanently in the village

You may not qualify if:

• Exclude families with a child who is known to be allergic to egg
• Exclude families with a child who is diagnosed as malnourished (moderate malnutrition (MAM) or severe malnutrition (SAM)
• Exclude women who do not live with the child

Sponsors & Collaborators

• University of Saskatchewan: lead
• Hawassa University: collaborator

Study Sites (1)

Hawassa University

Awasa, Ethiopia

Location

Related Publications (3)

• Kebede A, N Retta, C Abuye, SJ Whiting, M Kassaw, T Zeru, MW Yohannes, D Zerfu, M Tessema, MK. Malde. Minimizing bioavailability of fluoride through addition of calcium-magnesium citrate or a calcium and magnesium-containing vegetable to the diets of growing rats. International Journal of Biochemistry Research & Review. 10(2): 1-8. 2016a

  BACKGROUND

• Kebede A, Retta N, Abuye C, Whiting SJ, Kassaw M, Zeru T, Tessema M, Kjellevold M. Dietary Fluoride Intake and Associated Skeletal and Dental Fluorosis in School Age Children in Rural Ethiopian Rift Valley. Int J Environ Res Public Health. 2016 Jul 26;13(8):756. doi: 10.3390/ijerph13080756.

  PMID: 27472351 BACKGROUND

• Mulualem D, Hailu D, Tessema M, Whiting SJ. Efficacy of Calcium-Containing Eggshell Powder Supplementation on Urinary Fluoride and Fluorosis Symptoms in Women in the Ethiopian Rift Valley. Nutrients. 2021 Mar 24;13(4):1052. doi: 10.3390/nu13041052.

  PMID: 33804976 DERIVED

MeSH Terms

Conditions

Fluoride Poisoning; Thinness; Growth Disorders; Fluorosis, Dental

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Susan Whiting, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Chickens are how we intervene and this is not possible to "blind'. Two villages will be far apart. We will not disclose nature of intervention to examiners.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Model Details: Subjects to be drawn from two simlar villages: one is intervention village and other is control village.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 28, 2017
• Study Start: January 2, 2018
• Primary Completion: December 1, 2018
• Study Completion: June 30, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)