Vitamin A DeficiencyNCT02363985
Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection
A study testing Mega-dose of vitamin A supplement in people with Vitamin A Deficiency, run by Ethiopian Public Health Institute at 1 site in Ethiopia.
Trial summary
The combination of infectious diseases and malnutrition is the most prevalent, preventable public health problem in the world, responsible for millions of deaths annually, particularly in infants and children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Mega-dose of vitamin A supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Mar 2017to 30 Jun 2017
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-5 years, planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrollment.
Who cannot join
- severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Ethiopia
The combination of infectious diseases and malnutrition is the most prevalent, preventable public health problem in the world, responsible for millions of deaths annually, particularly in infants and children. Approximately 13 million children die each year in developing countries from infectious diseases, with the majority of these deaths related to malnutrition. The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption, nutrient loss or increased metabolic needs. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or more of a defined population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating concentrations of serum retinol are reduced by infections and in such situations serum retinol concentration is not a good indicator of vitamin A status. Serum acute-phase proteins can indicate the severity and duration of an infection. Correcting vitamin A deficiency is addressed in Ethiopia through vitamin A supplementation of children, dietary diversity and using bio-fortified foods. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most area of the country. Evaluation of vitamin A status is relatively insensitive when based on changes in serum retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin A status. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum of deficient to excessive stores.
Read the detailed description
Vitamin A deficiency is the leading cause of preventable blindness in children and is associated with a higher risk of under five mortality. Approximately 250,000 to 500,000 children in developing countries become blind each year owing to vitamin A deficiency, with the highest prevalence in South Asia and Africa. In Africa, many countries have implemented vitamin A interventions of mega-dose supplementation for children under 5 years, sometimes in combination with food fortification programs.
Vitamin A deficiency is a major nutritional concern; with more than 37.7% of under five children being vitamin A deficient by serum retinol and 50.7% had been sick in the previous 15 days in Ethiopia. Vitamin A deficiency is addressed in the country through vitamin A supplementation every six months for 6-59 months of children and during the first 45 days of delivery for lactating mothers. There are also other vitamin A intervention programs like bio-fortification of orange flesh sweet potato (OFSP) in pocket areas. Unfortunately, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most African countries including Ethiopia. This is because serum retinol concentration decreases during infection due to the acute phase response.
The overall national prevalence of any helminthes infection in Ethiopia was 29.8% with variable degree of prevalence among regions, where by southern nation nationality people (SNNP) (51%) and Gambella (51%) have the highest prevalence. A survey in 13 foods for education program-supported schools in the SNNP region indicated that prevalence of soil transmitted helminthiasis infections are 44.4%. The proportion of school children infected with any parasite species was 55.4%. A. lumbricoides was the most prevalent species 32.1%, followed by hookworm 21.7%.
Forty seven subjects (26 male and 21 female) met the survey definition of smear positive tuberculosis (TB) cases, with a prevalence of 108/100,000 (72-138). From smear positive TB cases, 37(78.7%) were new cases, 2(4.3%) were on treatment, and 8(17%) were previously treated in the last five years. Malaria prevalence is 4.5% in the malaria endemic area.
Evaluation of Vitamin A status is relatively insensitive when based on changes in serum retinol, which is homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A are the best indicator of vitamin A status, but cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficiency and effectiveness of intervention programs. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum from deficient to excessive vitamin A.
Hence, this project will assess the vitamin A and inflammatory status of 3-5 year old children 4-5 months after their semi-annual mega-dose vitamin A supplementation. The results will indicate the proportions of sampled children with low, normal or high vitamin A status, how inflammation (from obesity or recent infection or injury) affects assessment of vitamin A status using different vitamin A assessment methods, and how status differs by country, in possible association with food fortification practices.
Gap /Problem /Needs Analysis
The combination of infectious diseases and malnutrition is the most prevalent, preventable public health problem in the world, responsible for millions of deaths annually, particularly in infants and children. Approximately 13 million children die each year in developing countries from infectious diseases, with the majority of these deaths related to malnutrition. The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition through decreased appetite and food intake, nutrient mal-absorption, nutrient loss or increased metabolic needs. Severe malnutrition often masks symptoms and signs of infectious diseases making prompt clinical diagnosis and treatment very difficult. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or more of a defined population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating concentrations of serum retinol are reduced by infections and in such situations serum retinol concentration is not a good indicator of vitamin A status. Infections are accompanied by an acute phase response, and serum acute-phase proteins can indicate the severity and duration of an infection. Acute-phase proteins, such as C-reactive protein (CRP), increase within the first 6h of infection, and reach their maximum concentrations within 24-48h. However, α1-acid-glycoprotein (AGP) rises more slowly, with maximum concentrations 2-5 days after infection. Vitamin A deficiency is a major nutritional concern in poor societies affecting 190 million children globally.
Vitamin A is an essential nutrient needed for the visual system, and maintenance of cell function for growth, epithelial integrity, red blood cell production, immunity and reproduction. All infants are born with low stores and depend on vitamin A from breast milk to initially accumulate and maintain adequate stores. Infants of vitamin A depleted women are at greater risk of becoming vitamin A deficient early in life, especially if they are not breast fed. Correcting vitamin A deficiency is addressed by some African countries through vitamin A supplementation of children and food fortification programs. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most African countries. Evaluation of vitamin A status is relatively insensitive when based on changes in serum retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin A status. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum of deficient to excessive stores. Thus, this technique can be used for assessing vitamin A status in populations at risk of excessive status due to exposure to too much vitamin A through combined supplementation and consumption of fortified foods and/or preformed vitamin A-rich foods. The aim of this project is to use nuclear techniques to evaluate vitamin A nutritional status of young children during semi-annual administration of vitamin A supplements, and to assess how this relates to infection status.
The International Atomic Energy Agency (IAEA) has provided significant support on use of stable isotopes in assessing body composition and breast milk to Member States in Africa, it is now establishing the stable isotope technique to assess vitamin A body stores in Cameroon and Zambia (and additional implementation is possible in other country) for use throughout the region. These inputs will be used in this project to provide key information to stakeholders on how vitamin A intervention programs affect vitamin A status in children and how infections affect vitamin A status or validity of stable isotope techniques.
Role of nuclear technology The nuclear techniques used will be the deuterated- and 13 Carbon-retinol body pool measurements to assess vitamin A status. These nuclear methods are useful across the continuum of nutritional status from deficient to adequate to excess, in contrast with the more common measurement of serum retinol concentrations. In addition, the presence of infection/inflammation is less likely to interfere with interpretation of the nuclear method than that of the serum retinol method, but this will be investigated in this series of studies. This method is already being established in 2-3 countries and the serum retinol method is established in approximately 8 countries. Further use of the deuterated retinol body pool size nuclear method will contribute to capacity building in Africa, where vitamin A supplementation of children and widespread fortification are routine. The combination of multiple vitamin A interventions requires continuous monitoring. The IAEA is expected to provide technical and logistical support for the use of isotope dilution methods and facilitate Fellowships, Training, Scientific Visits, Expert Missions and Supplies.
- Conditions
- Vitamin A Deficiency
- Being tested
- Mega-dose of vitamin A supplement
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mega-dose of vitamin A supplementDietary supplement
vitamin A supplementation normally given every six months for under five children in Ethiopia. In addition, there is also dietary intervention like orange flash sweet potato and promotion of other vitamin A rich foods to tackle vitamin A deficiency in Ethiopia.
| Study group | Role | What they receive |
|---|---|---|
| Multiple vitamin A exposer | Other | 55 children who are using
* Mega-dose vitamin A supplementation
* Food diversification (promotion and education on vitamin A rich food consumption)
* Promotion of orange flash sweet potato production and consumption in collaboration with international potato center (CIP) in one of the study area Receives: Dietary Supplement: Mega-dose of vitamin A supplement |
| Only vitamin A supplementation | Other | 55 children who are using
* Mega-dose vitamin A supplementation
* Food diversification (promotion and education on vitamin A rich food consumption) Receives: Dietary Supplement: Mega-dose of vitamin A supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body pool size vitamin A (µmol)
estimate the total body pool size vitamin A in preschool child in Ethiopia using stable isotope technique
Measured: within the coming 2 years
Liver Vitamin A store (µmol/g)
Liver Vit A store (µmol/g) cut off <= 0.07
Measured: within the coming 2 years
Serum retinol (µmol/l)
Serum retinol (µmol/l) cut off <= 0.7
Measured: within the coming 2 years
Secondary outcomes (5)
level of infection
AGP and CRP
Measured: within the coming 2 years
dietary intake
mean intake of beta carotene and dietary diversity score using 24 hour dietary recall
Measured: within the coming 2 years
Anthropometry measurement
Weight for Height Z-score, Weight for Age Z-score, Height for Age Z-score and middle upper arm circumference
Measured: within the coming 2 years
socioeconomic status
household (HH) family size, marital status of the mother, head of the HH, source of drinking wate, highest level of education the head of HH attend
Measured: within the coming 2 years
Morbidity
medical history of the child enrolled in the study such as diarrhea, cough, fever, malaria, rashes, measles, vaccination, vitamin A supplementation, durg for intestinal deworming, iron supplementation.
Measured: within the coming 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study start1 Mar 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethiopian Public Health Institute
- Sponsor type
- Other government
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Principal investigator, Tesfaye Hailu, Ethiopian Public Health Institute
- Investigators
- Cornelia Loechl, PhD, Study director, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363985
- Sponsor's protocol ID
- EPHI_IAEA_P6047
- Status last verified
- Dec 2017
- First submitted
- 10 Feb 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Ethiopia
- ClinicalTrials.gov ID
- NCT02363985
- Acronym / sponsor ID
- EPHI_IAEA_P6047
- Conditions
- Vitamin A Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Ethiopian Public Health InstituteOther government
- Collaborators
- International Atomic Energy Agency
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 16 Feb 2015 (estimated)
- 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.
The combination of infectious diseases and malnutrition is the most prevalent, preventable public health problem in the world, responsible for millions of deaths annually, particularly in infants and children. Approximately 13 million children die each year in developing countries from infectious diseases, with the majority of these deaths related to malnutrition. The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption, nutrient loss or increased metabolic needs. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or more of a defined population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating concentrations of serum retinol are reduced by infections and in such situations serum retinol concentration is not a good indicator of vitamin A status. Serum acute-phase proteins can indicate the severity and duration of an infection. Correcting vitamin A deficiency is addressed in Ethiopia through vitamin A supplementation of children, dietary diversity and using bio-fortified foods. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most area of the country. Evaluation of vitamin A status is relatively insensitive when based on changes in serum retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin A status. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum of deficient to excessive stores.
Detailed description
Vitamin A deficiency is the leading cause of preventable blindness in children and is associated with a higher risk of under five mortality. Approximately 250,000 to 500,000 children in developing countries become blind each year owing to vitamin A deficiency, with the highest prevalence in South Asia and Africa. In Africa, many countries have implemented vitamin A interventions of mega-dose supplementation for children under 5 years, sometimes in combination with food fortification programs.
Vitamin A deficiency is a major nutritional concern; with more than 37.7% of under five children being vitamin A deficient by serum retinol and 50.7% had been sick in the previous 15 days in Ethiopia. Vitamin A deficiency is addressed in the country through vitamin A supplementation every six months for 6-59 months of children and during the first 45 days of delivery for lactating mothers. There are also other vitamin A intervention programs like bio-fortification of orange flesh sweet potato (OFSP) in pocket areas. Unfortunately, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most African countries including Ethiopia. This is because serum retinol concentration decreases during infection due to the acute phase response.
The overall national prevalence of any helminthes infection in Ethiopia was 29.8% with variable degree of prevalence among regions, where by southern nation nationality people (SNNP) (51%) and Gambella (51%) have the highest prevalence. A survey in 13 foods for education program-supported schools in the SNNP region indicated that prevalence of soil transmitted helminthiasis infections are 44.4%. The proportion of school children infected with any parasite species was 55.4%. A. lumbricoides was the most prevalent species 32.1%, followed by hookworm 21.7%.
Forty seven subjects (26 male and 21 female) met the survey definition of smear positive tuberculosis (TB) cases, with a prevalence of 108/100,000 (72-138). From smear positive TB cases, 37(78.7%) were new cases, 2(4.3%) were on treatment, and 8(17%) were previously treated in the last five years. Malaria prevalence is 4.5% in the malaria endemic area.
Evaluation of Vitamin A status is relatively insensitive when based on changes in serum retinol, which is homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A are the best indicator of vitamin A status, but cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficiency and effectiveness of intervention programs. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum from deficient to excessive vitamin A.
Hence, this project will assess the vitamin A and inflammatory status of 3-5 year old children 4-5 months after their semi-annual mega-dose vitamin A supplementation. The results will indicate the proportions of sampled children with low, normal or high vitamin A status, how inflammation (from obesity or recent infection or injury) affects assessment of vitamin A status using different vitamin A assessment methods, and how status differs by country, in possible association with food fortification practices.
Gap /Problem /Needs Analysis
The combination of infectious diseases and malnutrition is the most prevalent, preventable public health problem in the world, responsible for millions of deaths annually, particularly in infants and children. Approximately 13 million children die each year in developing countries from infectious diseases, with the majority of these deaths related to malnutrition. The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition through decreased appetite and food intake, nutrient mal-absorption, nutrient loss or increased metabolic needs. Severe malnutrition often masks symptoms and signs of infectious diseases making prompt clinical diagnosis and treatment very difficult. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or more of a defined population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating concentrations of serum retinol are reduced by infections and in such situations serum retinol concentration is not a good indicator of vitamin A status. Infections are accompanied by an acute phase response, and serum acute-phase proteins can indicate the severity and duration of an infection. Acute-phase proteins, such as C-reactive protein (CRP), increase within the first 6h of infection, and reach their maximum concentrations within 24-48h. However, α1-acid-glycoprotein (AGP) rises more slowly, with maximum concentrations 2-5 days after infection. Vitamin A deficiency is a major nutritional concern in poor societies affecting 190 million children globally.
Vitamin A is an essential nutrient needed for the visual system, and maintenance of cell function for growth, epithelial integrity, red blood cell production, immunity and reproduction. All infants are born with low stores and depend on vitamin A from breast milk to initially accumulate and maintain adequate stores. Infants of vitamin A depleted women are at greater risk of becoming vitamin A deficient early in life, especially if they are not breast fed. Correcting vitamin A deficiency is addressed by some African countries through vitamin A supplementation of children and food fortification programs. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most African countries. Evaluation of vitamin A status is relatively insensitive when based on changes in serum retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin A status. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum of deficient to excessive stores. Thus, this technique can be used for assessing vitamin A status in populations at risk of excessive status due to exposure to too much vitamin A through combined supplementation and consumption of fortified foods and/or preformed vitamin A-rich foods. The aim of this project is to use nuclear techniques to evaluate vitamin A nutritional status of young children during semi-annual administration of vitamin A supplements, and to assess how this relates to infection status.
The International Atomic Energy Agency (IAEA) has provided significant support on use of stable isotopes in assessing body composition and breast milk to Member States in Africa, it is now establishing the stable isotope technique to assess vitamin A body stores in Cameroon and Zambia (and additional implementation is possible in other country) for use throughout the region. These inputs will be used in this project to provide key information to stakeholders on how vitamin A intervention programs affect vitamin A status in children and how infections affect vitamin A status or validity of stable isotope techniques.
Role of nuclear technology The nuclear techniques used will be the deuterated- and 13 Carbon-retinol body pool measurements to assess vitamin A status. These nuclear methods are useful across the continuum of nutritional status from deficient to adequate to excess, in contrast with the more common measurement of serum retinol concentrations. In addition, the presence of infection/inflammation is less likely to interfere with interpretation of the nuclear method than that of the serum retinol method, but this will be investigated in this series of studies. This method is already being established in 2-3 countries and the serum retinol method is established in approximately 8 countries. Further use of the deuterated retinol body pool size nuclear method will contribute to capacity building in Africa, where vitamin A supplementation of children and widespread fortification are routine. The combination of multiple vitamin A interventions requires continuous monitoring. The IAEA is expected to provide technical and logistical support for the use of isotope dilution methods and facilitate Fellowships, Training, Scientific Visits, Expert Missions and Supplies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple vitamin A exposer | Other | Dietary Supplement: Mega-dose of vitamin A supplement55 children who are using * Mega-dose vitamin A supplementation * Food diversification (promotion and education on vitamin A rich food consumption) * Promotion of orange flash sweet potato production and consumption in collaboration with international potato center (CIP) in one of the study area |
| Only vitamin A supplementation | Other | Dietary Supplement: Mega-dose of vitamin A supplement55 children who are using * Mega-dose vitamin A supplementation * Food diversification (promotion and education on vitamin A rich food consumption) |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3-5 years, planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrollment.
Key exclusion criteria (1 listed)
- severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.
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 |
|---|---|---|
| Mega-dose of vitamin A supplementvitamin A supplementation normally given every six months for under five children in Ethiopia. In addition, there is also dietary intervention like orange flash sweet potato and promotion of other vitamin A rich foods to tackle vitamin A deficiency in Ethiopia. | Dietary supplement | Multiple vitamin A exposer, Only vitamin A supplementation |
Primary outcome
Total body pool size vitamin A (µmol)
Time frame: within the coming 2 years
estimate the total body pool size vitamin A in preschool child in Ethiopia using stable isotope technique
Liver Vitamin A store (µmol/g)
Time frame: within the coming 2 years
Liver Vit A store (µmol/g) cut off <= 0.07
Serum retinol (µmol/l)
Time frame: within the coming 2 years
Serum retinol (µmol/l) cut off <= 0.7
5 secondary outcomes
level of infection
Time frame: within the coming 2 years
dietary intake
Time frame: within the coming 2 years
Anthropometry measurement
Time frame: within the coming 2 years
socioeconomic status
Time frame: within the coming 2 years
Morbidity
Time frame: within the coming 2 years
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 12 Dec 2017.
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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.
Cornelia Loechl, PhD study director
International Atomic Energy Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mega-dose of vitamin A supplement in people with Vitamin A Deficiency, run by Ethiopian Public Health Institute 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 1 inclusion and 1 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 12 Dec 2017. 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?
Total body pool size vitamin A (µmol) (time frame: within the coming 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2017.