Fluoride PoisoningNCT03355222
Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
A study testing Promotion of chicken eggs in people with Fluoride Poisoning and Hemoglobin, run by University of Saskatchewan at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 months
- Conditions the study is for
- Fluoride Poisoning, Hemoglobin, Underweight
- What is being tested?
- Promotion of chicken eggs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteEthiopia
- Study dates
- 2 Jan 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All women with a child age 6 to 18 months and their child living permanently in the village
- the woman does not have to be biological mother Exclusion Criteria:
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Fluoride Poisoning, Hemoglobin, Underweight, Stunting, Development; Delayed, Mental, Fluorosis, Dental
- Being tested
- Promotion of chicken eggs
- Keywords
- complementary feeding, calcium
- Medical subject headings
- Fluoride Poisoning, Thinness, Growth Disorders, Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of chicken eggsBehavioural
Community is provided with chickens and young children are to receive one egg a day; selected mothers will consume eggshell.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Promotion of chicken eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent fluoride absorption
Change in urinary fluoride corrected for creatinine as a measure of F absorption
Measured: 6 months
Secondary outcomes (5)
Growth in young children
weight for age
Measured: 6 months and 12 months
Functional indicators of fluorosis
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
Measured: 6 months
Hemoglobin (Hb)
Blood levels of Hb
Measured: 6 months and 12 months
Knowledge, attitude and practices (KAP) for egg
Questionnaire assessment of KAP
Measured: 6 and 12 months
Linear growth in young children
length for age
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start2 Jan 2018
- Primary completion1 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fluoride PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects to be drawn from two simlar villages: one is intervention village and other is control village.
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Hawassa University
- Responsible party
- Principal investigator, Susan Whiting, University of Saskatchewan
- Investigators
- Susan Whiting, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355222
- Sponsor's protocol ID
- HU-UoS-EGGSHELL-FLUORIDE
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We would find it difficult to keep records for extraction of participant data as the local language will be used to store records.
Publications
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
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.
PubMed 27472351Mulualem 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.
PubMed 33804976
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
- ClinicalTrials.gov ID
- NCT03355222
- Acronym / sponsor ID
- HU-UoS-EGGSHELL-FLUORIDE
- Conditions
- Fluoride Poisoning, Hemoglobin, Underweight, Stunting, Development; Delayed, Mental, Fluorosis, Dental
- Keywords
- complementary feeding, calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Hawassa University
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects to be drawn from two simlar villages: one is intervention village and other is control village.
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –No intervention: The community receives no chickens and no special education is provided. |
| Experimental: providing chickens and egg shell | Experimental | Behavioral: Promotion of chicken eggsExperimental: 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. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- All women with a child age 6 to 18 months and their child living permanently in the village
- the woman does not have to be biological mother Exclusion Criteria:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promotion of chicken eggsCommunity is provided with chickens and young children are to receive one egg a day; selected mothers will consume eggshell. | Behavioural | Experimental: providing chickens and egg shell |
Primary outcome
Apparent fluoride absorption
Time frame: 6 months
Change in urinary fluoride corrected for creatinine as a measure of F absorption
5 secondary outcomes
Growth in young children
Time frame: 6 months and 12 months
Functional indicators of fluorosis
Time frame: 6 months
Hemoglobin (Hb)
Time frame: 6 months and 12 months
Knowledge, attitude and practices (KAP) for egg
Time frame: 6 and 12 months
Linear growth in young children
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- BackgroundKebede 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: PubMed 27472351Kebede 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.
- Derived from this study: PubMed 33804976Mulualem 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.
- Individual participant dataSharing planned: No. We would find it difficult to keep records for extraction of participant data as the local language will be used to store records.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Whiting, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of chicken eggs in people with Fluoride Poisoning and Hemoglobin, run by University of Saskatchewan at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent fluoride absorption (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03355222, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.