Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
Condition: Fluoride Poisoning; Hemoglobin; Underweight; Stunting; Development; Delayed, Mental; Fluorosis, Dental; Fluorosis; Skeletal; Zinc Deficiency
MeSH terms: Fluorosis, Dental; Thinness; Poisoning; Fluoride Poisoning
Study type: Interventional

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.
    

Detailed description: 
      This is a Proof of Principle study with a treatment ("Intervention") group and a parallel
      control group for delivering eggshell powder to mothers in the setting of a chilken
      intervention. The control and intervention groups will come from the same region in southern
      Ethiopia where fluorosis is known to occur, with active intervention for 6 months followed by
      observation for a further 6 months. The Intervention is providing daily eggshell calcium to a
      subset of mothers, with all eligible young children receiving at least one egg a day. The
      treatment group consists of mothers and young children in a community where study families
      will receive two chickens each, and the control group are mothers and young children not
      having chickens for the first six months, but who will be gifted with chickens at 6 months.
      Along with receiving chickens, the intervention group will receive training in use of egg, as
      well as assistance in caring for chickens, throughout the first 6 months. In the second
      6-months, the participants' use of eggs will be monitored. In the control group, provision of
      chickens after 6 months will be accompanied by training but for a shorter duration, and
      monitoring of use of egg will provide information on whether minimal support can effectively
      allow for adoption of new food sources into a community.

      Study participants are all mothers with children aged between 6-18 months old in two
      participating kebeles (villages), one randomly assigned as intervention, the other as
      control. The age group of the child is selected because it is the time of introduction of
      complementary food and it will be easier to see the clear effect of egg on the children's
      growth. Mothers are lactating therefore at a time for maximal calcium utilization. While eggs
      are not commonly eaten in rural Ethiopia, it is due to expense, not to unfamiliarity. In the
      Intervention community prior to baseline measurements, each family of the mother-child pair
      will receive two chickens at a "ceremony" that marks the responsibility given to the family
      to provide one egg per day to the child. In a subset of mothers, they will consent to use
      eggshell. This is modified from what the investigators did in a pilot study (NCT02791100) and
      the investigators found use of egg by the child was 85% throughout the 6 month time-period.
      One lesson learned was to purchase older chickens that are immediately capable of laying
      eggs. Second, in this intervention the child will not receive ESP.

      There will be formal follow-up observation at one community site with focus group discussion
      and key informant interviews, as a way to assess feasibility and practically of chicken
      donation in the future. This will be a convenience sample representing participant parents,
      community leaders, Agriculture Extension workers, Health extension workers, persons who were
      not directly involved. Those targeted for interviews will be the extension workers from whom
      feedback will be provided, while focus groups will be held with others who are able to attend
      a focus group session.

      Data checks will be provided by two doctoral students working on the project. Local
      supervisors will provide guidance. The students have written specific operating procedures
      (SOP) for all procedures. Missing data will be accounted for, but as this is a community
      based study group means will be used for most outcome measurements. Comparing of two
      means/the differences of means between the intervention and control groups will be done using
      independent two sample t-test. Continuous outcomes will be analyzed using paired t-test.
      Bivariate analysis will be used to see the overall effect of independent variables and then
      further multivariate analysis (multiple linear regressions) will be done to see the effect of
      each independent variable. Both crude and adjusted risk ratio with 95% confidence interval
      will be reported. Other variables and relevant findings will be also analyzed using proper
      statistical test/analysis techniques and reported accordingly. P-value of less than 0.05 will
      be taken as significant
    

Intervention name(s): Promotion of chicken eggs
Intervention type(s): Behavioral
Intervention description(s): Community is provided with chickens and young children are to receive one egg a day; selected mothers will consume eggshell.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects to be drawn from two simlar villages: one is intervention village and other is control village.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: complementary feeding; calcium