Ignite Creation Date:
2024-05-06 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03355222
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2017-11-09
Brief Title:
Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday 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 childrens 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 meansthe 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 testanalysis techniques and reported accordingly P-value of less than 005 will be taken as significant
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 childrens 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 meansthe 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 testanalysis techniques and reported accordingly P-value of less than 005 will be taken as significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None