Vitamin A DeficiencySUPERKIDNCT02996513
Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method
A study testing Retinol Isotope Dilution (RID) in people with Vitamin A Deficiency and Malaria, run by Wageningen University at 1 site in Nigeria.
Trial summary
For assessing body retinol pools in preschool children, it is recommended that a blood sample is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A should be controlled. Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency, Malaria, Inflammation
- What is being tested?
- Retinol Isotope Dilution (RID)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNigeria
- Study dates
- Oct 2016to 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 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy
- Between 36 and 59 months of age
- Living in the community of Telemu, Osun State, Nigeria, or its neighbouring communities
Who cannot join
- Active or recent disease with a potential effect on study outcome
- Hb concentration <70 g/dL
- Mental state that is incompatible with participation in the study
- Recent exposure to 13C-retinol stable isotopes
- Unwillingness to participate by verbal or physical expression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method in Preschool Nigerian Children Living in an Area With a High Malaria Burden
For assessing body retinol pools in preschool children, it is recommended that a blood sample is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A should be controlled. Shortening of this period as has been validated for adults would reduce the burden for the children as well as improve research efficiency. The aim is to validate a 4-day protocol for assessing body retinol pools in preschool children by modelling data derived by retinol isotope dilution (RID) method. Venous blood samples will be collected of 60 children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing in subgroups of 6 children, randomly divided over the 10 additional time points. Body retinol pools will be modelled, and the time point at which a parsimonious model applies (presumably at day 4) will be assessed.
Read the detailed description
For assessing body retinol pools in preschool children, it is recommended that a blood sample is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A should be controlled. Shortening of this period as has been validated for adults would reduce the burden for the children as well as improve research efficiency. The aim is to validate a 4-day protocol for assessing body retinol pools in preschool children by modelling data derived by retinol isotope dilution (RID) method. A secondary aim is to compare body retinol pools between children with and without inflammation and to assess the effect of asymptomatic malaria on model parameters. Preschool children (n=60), 36-59 months of age, residing in Telemu, Osun State, Nigeria will be recruited for the study. The study design is an observational pre/post study, for which body retinol pools will be measured using the RID method. Venous blood samples will be collected of all children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing in subgroups of 6 children, randomly divided over the 10 additional time points. Children presenting with asymptomatic malaria will be treated, and a convenience subsample (n=10) will undergo a second assessment of body retinol pools determined with a venous blood collection on day 4 post-dosing only. Body retinol pools will be modelled, and the time point at which a parsimonious model applies (presumably at day 4) will be assessed. Presence of asymptomatic malaria and markers of inflammation will be assessed in all children at all time points. Body retinol pools and model parameters between subgroups of children with and without asymptomatic malaria and/or inflammation will be compared. Pre/post comparisons of body retinol pool estimates will be done for the follow up subsample.
- Conditions
- Vitamin A Deficiency, Malaria, Inflammation
- Being tested
- Retinol Isotope Dilution (RID)
- Keywords
- Vitamin A status, Retinol Isotope Dilution, Nigeria, Preschool children, Malaria, Inflammation
- Medical subject headings
- Vitamin A Deficiency, Malaria, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinol Isotope Dilution (RID)Other
13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools
| Study group | Role | What they receive |
|---|---|---|
| Retinol Isotope dilution (RID) | Experimental | A once-off dose of 0.4 mg 13C4-retinyl acetate will be administered to subjects as a capsule Receives: Other: Retinol Isotope Dilution (RID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A status
Body retinol pool
Measured: 28 days
Secondary outcomes (7)
Prevalence of malaria (plasmodium falciparum)
Percentage of children with malaria (Plasmodium falciparum) as determined by a rapid test (CareStart Malaria HRP2) and confirmed by PCR.
Measured: 28 days
Prevalence of inflammation
Percentage of children with C-reactive protein (CRP) >5 mg/L and/or alpha-glycoprotein (AGP) >1 g/L
Measured: 28 days
Serum retinol
Serum concentration of retinol (HPLC)
Measured: 28 days
Blood haemoglobin concentration
Haemoglobin concentration (Quikread)
Measured: 28 days
Ferritin concentration
Serum concentration of ferritin (ELISA)
Measured: 28 days
Soluble transferrin receptor concentration
Serum concentration of soluble transferrin receptor concentration (ELISA)
Measured: 28 days
Retinol binding protein
Serum concentration of retinol binding protein (ELISA)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionJun 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ibadan, Newcastle University, University of California, Davis, Penn State University, HarvestPlus
- Responsible party
- Sponsor
- Investigators
- Alida Melse-Boonstra, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996513
- Sponsor's protocol ID
- WageningenU
- Acronym
- SUPERKID
- Status last verified
- Aug 2017
- First submitted
- 11 Nov 2016
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method in Preschool Nigerian Children Living in an Area With a High Malaria Burden
- ClinicalTrials.gov ID
- NCT02996513
- Acronym / sponsor ID
- SUPERKID / WageningenU
- Conditions
- Vitamin A Deficiency, Malaria, Inflammation
- Keywords
- Vitamin A status, Retinol Isotope Dilution, Nigeria, Preschool children, Malaria, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- University of Ibadan, Newcastle University, University of California, Davis, Penn State University, HarvestPlus
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Dec 2016 (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.
For assessing body retinol pools in preschool children, it is recommended that a blood sample is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A should be controlled. Shortening of this period as has been validated for adults would reduce the burden for the children as well as improve research efficiency. The aim is to validate a 4-day protocol for assessing body retinol pools in preschool children by modelling data derived by retinol isotope dilution (RID) method. Venous blood samples will be collected of 60 children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing in subgroups of 6 children, randomly divided over the 10 additional time points. Body retinol pools will be modelled, and the time point at which a parsimonious model applies (presumably at day 4) will be assessed.
Detailed description
For assessing body retinol pools in preschool children, it is recommended that a blood sample is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A should be controlled. Shortening of this period as has been validated for adults would reduce the burden for the children as well as improve research efficiency. The aim is to validate a 4-day protocol for assessing body retinol pools in preschool children by modelling data derived by retinol isotope dilution (RID) method. A secondary aim is to compare body retinol pools between children with and without inflammation and to assess the effect of asymptomatic malaria on model parameters. Preschool children (n=60), 36-59 months of age, residing in Telemu, Osun State, Nigeria will be recruited for the study. The study design is an observational pre/post study, for which body retinol pools will be measured using the RID method. Venous blood samples will be collected of all children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing in subgroups of 6 children, randomly divided over the 10 additional time points. Children presenting with asymptomatic malaria will be treated, and a convenience subsample (n=10) will undergo a second assessment of body retinol pools determined with a venous blood collection on day 4 post-dosing only. Body retinol pools will be modelled, and the time point at which a parsimonious model applies (presumably at day 4) will be assessed. Presence of asymptomatic malaria and markers of inflammation will be assessed in all children at all time points. Body retinol pools and model parameters between subgroups of children with and without asymptomatic malaria and/or inflammation will be compared. Pre/post comparisons of body retinol pool estimates will be done for the follow up subsample.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinol Isotope dilution (RID) | Experimental | Other: Retinol Isotope Dilution (RID)A once-off dose of 0.4 mg 13C4-retinyl acetate will be administered to subjects as a capsule |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Apparently healthy
- Between 36 and 59 months of age
- Living in the community of Telemu, Osun State, Nigeria, or its neighbouring communities
Key exclusion criteria (5 listed)
- Active or recent disease with a potential effect on study outcome
- Hb concentration <70 g/dL
- Mental state that is incompatible with participation in the study
- Recent exposure to 13C-retinol stable isotopes
- Unwillingness to participate by verbal or physical expression
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 |
|---|---|---|
| Retinol Isotope Dilution (RID)13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools | Other | Retinol Isotope dilution (RID) |
Primary outcome
Vitamin A status
Time frame: 28 days
Body retinol pool
7 secondary outcomes
Prevalence of malaria (plasmodium falciparum)
Time frame: 28 days
Prevalence of inflammation
Time frame: 28 days
Serum retinol
Time frame: 28 days
Blood haemoglobin concentration
Time frame: 28 days
Ferritin concentration
Time frame: 28 days
Soluble transferrin receptor concentration
Time frame: 28 days
Retinol binding protein
Time frame: 28 days
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 25 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Alida Melse-Boonstra, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinol Isotope Dilution (RID) in people with Vitamin A Deficiency and Malaria, run by Wageningen University at 1 site in Nigeria.
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 3 inclusion and 5 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 25 Aug 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 Nigeria. 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?
Vitamin A status (time frame: 28 days). 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 25 Aug 2017.