Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
|ClinicalTrials.gov Identifier: NCT03355222|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fluoride Poisoning Hemoglobin Underweight Stunting Development; Delayed, Mental Fluorosis, Dental Fluorosis; Skeletal Zinc Deficiency||Behavioral: Promotion of chicken eggs||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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)|
|Masking Description:||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.|
|Official Title:||Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia|
|Actual Study Start Date :||January 2, 2018|
|Actual Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||June 2019|
No Intervention: No Intervention
No intervention: The community receives no chickens and no special education is provided.
Experimental: Experimental: providing chickens and egg shell
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
Community is provided with chickens and young children are to receive one egg a day; selected mothers will consume eggshell.
- Apparent fluoride absorption [ Time Frame: 6 months ]Change in urinary fluoride corrected for creatinine as a measure of F absorption
- Growth in young children [ Time Frame: 6 months and 12 months ]weight for age
- Functional indicators of fluorosis [ Time Frame: 6 months ]Physical signs of fluorosis are assessment using a standard questionnaire developed by the investigators and subsequently published (Kebede et al., 2016). Briefly this consists of a questionnaire of signs and symptoms which can be added to obtain a score
- Hemoglobin (Hb) [ Time Frame: 6 months and 12 months ]Blood levels of Hb
- Knowledge, attitude and practices (KAP) for egg [ Time Frame: 6 and 12 months ]Questionnaire assessment of KAP
- Linear growth in young children [ Time Frame: 6 months and 12 months ]length for age
- Inhibition of zinc absorption [ Time Frame: 6 months ]serum zinc
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355222
|Principal Investigator:||Susan Whiting, PhD||University of Saskatchewan|