Healthy InfantsNCT03801161
Influence of Inflammation on Micronutrient Status Assessment
A study testing Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). in people with Healthy Infants, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
Trial summary
Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children. Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. Read more about this study
- Who is it for?
- Ages 9 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesBangladesh
- Study dates
- 1 Jun 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 9 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9 - 18 months of age
- Infants with normal body temperature and normal CRP (<5 mg/L)
- Infants receive breast milk from the mother at least once per day
- Mothers produce a breast milk containing 30-40 nmol vitamin A /g milk fat
- Infants received a high-dose vitamin A capsules at the time of the most recent national distribution campaign (within the last 2-4 months)
- Mother is 18 - 45 years of age
- Mother and her infant plan to stay in the study area for the duration of the study
Who cannot join
- Mother or infant has chronic disease
- Mother or infant has acute illness on the day of data collection
- Infant is anemic (Hb <90 g/L)
- Infant has weight for length <80% of the reference median
- Infants do not develop inflammation (CRP ≥5 mg/L) after PENTA vaccination
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Clinical Trail Unit (CTU), icddr,b.
Dhaka, 1212
Shaikh M Ahmad
Dhaka, 1212
About this study
Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children. Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. A total of 40 infants (9-18 mo of age) will participate in this study. Investigators will use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). The investigators will also use two different stable isotopic retinols for the assessment of total body vitamin A stores. Baseline blood samples (5 mL) will be obtained from all infants and then randomly selected 30 infants will receive PENTA vaccines, while the other 10 infants will receive no vaccines. 24 hours after vaccination a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP and on the same day, blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group. Thus estimated plasma micronutrients and vitamin A stores before and after inflammation will calculate the effects of inflammation on the interpretation of micronutrient deficiencies based on biochemical indicator assessment.
Read the detailed description
Background:
Subclinical micronutrient deficiencies remain a hidden aspect of malnutrition for which comprehensive data are lacking. Defining subclinical micronutrient deficiencies requires considering the prevalence of inflammation and its implications for the interpretation of micronutrient deficiencies based on biochemical indicator assessment. This study will provide a comprehensive profile of micronutrient status and antimicrobial resistance in a cohort of young children living in the densely populated urban slum.
Hypothesis:
- Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children II. Micronutrient assessments can be performed successfully using finger/heel prick blood samples with microsamplers, thus increasing the ease of blood collection and reducing costs for cold storage and transport to the analytical laboratory.
Specific Objectives:
Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. Our secondary aim is to test the applicability of a blood spot device allowing the determination of micronutrient status in field settings. Our exploratory objective is to make a comparative analysis of gut antimicrobial resistance genes (AMR) and resistome profile in children.
Methods:
A total of 40 infants (9-18 mo of age) will participate in this study. In this study, investigators will use two different stable isotopic vitamin A e.g., 13C10-retinyl acetate and 13C4-retinyl acetate. 400 μg of these isotopes, dissolved in 0.5 mL of sunflower oil, will be provided directly into the infant's mouth by using a direct replacement pipette. Mothers will be asked to breastfeed their infant after oral dosing to enhance absorption of the labeled vitamin A. Specific activity of 13C10- and 13C4- retinyl acetate in the blood samples will be measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS). On the day of blood collection, a 24-h dietary recall and weekly morbidity questionnaires will be used. Investigators will also use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). This vaccination is beneficial to the infants since the World Health Organization recommends a booster vaccination dose. At the end of the study, PENTA vaccines will also be provided to the study infants in the "no-vaccine" group.
On day 0, all infants (n=40) will receive an oral dose of 13C10-retinyl acetate, and blood samples (5 mL) will be taken on day 4. On day 7 all infants (n=40) will also receive another oral dose of 13C4-retinyl acetate. 3-day later randomly selected 30 infants will receive PENTA vaccines (day 10), while the other 10 infants will receive no vaccines. 24 hours after vaccination a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP (QuikRead go, Orion, Finland). On the same day (day 11), blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group (day 11). Thus plasma micronutrients and vitamin A stores estimates on day 4 and day 11 will evaluate the effects of inflammation on the plasma micronutrient status indicators and total body vitamin A store. Blood microsamplers will be tested alongside venous blood collection to assess the feasibility of finger/heel prick sampling. Fecal samples, local surface water, and wastewater samples will be collected to test the prevalence of AMR resitomes in children and their environment.
Outcome measures/variables:
- The following plasma biomarkers will be estimated before inflammation and 24 hours after inflammation
- Inflammation markers: C-reactive protein (CRP) (mg/L) and α1-acid glycoprotein (AGP) (g/L)
- Vitamin A status indicators: retinol (nmol/L), total body vitamin A stores (nmol), Retinol binding protein (RBP) (mg/L) and beta-carotene (nmol/L)
- Iron status indicators: ferritin (ug/L) and soluble transferrin receptor (mg/L)
- Folate/B12 status indicators: folate (nmol/L), methylmalonic acid (umol/L) and cobalamin (pmol/L)
- Trace element status indicators: selenium (ug/L), copper (ug/L) and thyroglobulin (ug/L).
- The usefulness of a microsampler device to collect blood samples for future micronutrient assessments.
- Assessment and contrast of AMR gene abundances and diversity to develop resistomes
- Conditions
- Healthy Infants
- Being tested
- Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).
- Keywords
- vitamin A, vitamin A isotope, vitamin D, ferritin, transferrin receptor, folate, cobalamin, beta-carotene, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).Biological
Pentavalent vaccine is being recommended to provide infants at 6wk, 10wk and 14wk of age. This vaccine also induces plasma CRP >5 mg/L in infants within 24 hours of immunization.
| Study group | Role | What they receive |
|---|---|---|
| Healthy infants | No intervention | Not described |
| Infants with an inflammatory condition | Experimental | Investigators will also use pentavalent (PENTA) vaccine as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). Receives: Biological: Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation marker C-reactive protein (CRP) levels in infants before and 1-day after inflammation
In infants (9-18 mo) plasma CRP levels (mg/L) will be estimated by ELISA before and 24 hours after inflammation. Paired t-test will be used to evaluate the difference.
Measured: 24 hours
Vitamin A status in infants before and 1-day after inflammation
In infants (9-18 mo) plasma retinol levels (nmol/L) will be estimated by HPLC before and 24 hours after inflammation.Paired t-test will be used to evaluate the difference.
Measured: 24 hours
Total body stores (TBS) of vitamin A in infants before and 1-day after inflammation
In infants (9-18 mo) TBS of vitamin A (nmol) will be estimated before and 24 hours after inflammation. TBS will be measured by calculating the specific activities of 13C10- and 13C4- retinyl acetate in the blood samples by using liquid chromatography-tandem mass spectrometry (LC/MS/MS) method. Paired t-test will be used to evaluate the difference.
Measured: 24 hours
Iron status in infants before and 1-day after inflammation
In infants (9-18 mo) plasma ferritin levels (ug/L) will be estimated by ELISA before and 24 hours after inflammation. Paired t-test will be used to evaluate the difference.
Measured: 24 hours
Iron status in infants before and 1-day after inflammation
In infants (9-18 mo) plasma soluble transferrin receptor (sTfR) concentration (mg/L) will be estimated by ELISA before and 24 hours after inflammation. Paired t-test will be used to evaluate the difference.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Jun 2018
- Primary completion31 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801161
- Sponsor's protocol ID
- PR-18006
- Status last verified
- Sep 2018
- First submitted
- 29 Mar 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Inflammation on Micronutrient Status Assessment
- ClinicalTrials.gov ID
- NCT03801161
- Acronym / sponsor ID
- PR-18006
- Conditions
- Healthy Infants
- Keywords
- vitamin A, vitamin A isotope, vitamin D, ferritin, transferrin receptor, folate, cobalamin, beta-carotene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 11 Jan 2019 (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.
Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children. Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. A total of 40 infants (9-18 mo of age) will participate in this study. Investigators will use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). The investigators will also use two different stable isotopic retinols for the assessment of total body vitamin A stores. Baseline blood samples (5 mL) will be obtained from all infants and then randomly selected 30 infants will receive PENTA vaccines, while the other 10 infants will receive no vaccines. 24 hours after vaccination a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP and on the same day, blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group. Thus estimated plasma micronutrients and vitamin A stores before and after inflammation will calculate the effects of inflammation on the interpretation of micronutrient deficiencies based on biochemical indicator assessment.
Detailed description
Background:
Subclinical micronutrient deficiencies remain a hidden aspect of malnutrition for which comprehensive data are lacking. Defining subclinical micronutrient deficiencies requires considering the prevalence of inflammation and its implications for the interpretation of micronutrient deficiencies based on biochemical indicator assessment. This study will provide a comprehensive profile of micronutrient status and antimicrobial resistance in a cohort of young children living in the densely populated urban slum.
Hypothesis:
- Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children II. Micronutrient assessments can be performed successfully using finger/heel prick blood samples with microsamplers, thus increasing the ease of blood collection and reducing costs for cold storage and transport to the analytical laboratory.
Specific Objectives:
Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. Our secondary aim is to test the applicability of a blood spot device allowing the determination of micronutrient status in field settings. Our exploratory objective is to make a comparative analysis of gut antimicrobial resistance genes (AMR) and resistome profile in children.
Methods:
A total of 40 infants (9-18 mo of age) will participate in this study. In this study, investigators will use two different stable isotopic vitamin A e.g., 13C10-retinyl acetate and 13C4-retinyl acetate. 400 μg of these isotopes, dissolved in 0.5 mL of sunflower oil, will be provided directly into the infant's mouth by using a direct replacement pipette. Mothers will be asked to breastfeed their infant after oral dosing to enhance absorption of the labeled vitamin A. Specific activity of 13C10- and 13C4- retinyl acetate in the blood samples will be measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS). On the day of blood collection, a 24-h dietary recall and weekly morbidity questionnaires will be used. Investigators will also use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). This vaccination is beneficial to the infants since the World Health Organization recommends a booster vaccination dose. At the end of the study, PENTA vaccines will also be provided to the study infants in the "no-vaccine" group.
On day 0, all infants (n=40) will receive an oral dose of 13C10-retinyl acetate, and blood samples (5 mL) will be taken on day 4. On day 7 all infants (n=40) will also receive another oral dose of 13C4-retinyl acetate. 3-day later randomly selected 30 infants will receive PENTA vaccines (day 10), while the other 10 infants will receive no vaccines. 24 hours after vaccination a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP (QuikRead go, Orion, Finland). On the same day (day 11), blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group (day 11). Thus plasma micronutrients and vitamin A stores estimates on day 4 and day 11 will evaluate the effects of inflammation on the plasma micronutrient status indicators and total body vitamin A store. Blood microsamplers will be tested alongside venous blood collection to assess the feasibility of finger/heel prick sampling. Fecal samples, local surface water, and wastewater samples will be collected to test the prevalence of AMR resitomes in children and their environment.
Outcome measures/variables:
- The following plasma biomarkers will be estimated before inflammation and 24 hours after inflammation
- Inflammation markers: C-reactive protein (CRP) (mg/L) and α1-acid glycoprotein (AGP) (g/L)
- Vitamin A status indicators: retinol (nmol/L), total body vitamin A stores (nmol), Retinol binding protein (RBP) (mg/L) and beta-carotene (nmol/L)
- Iron status indicators: ferritin (ug/L) and soluble transferrin receptor (mg/L)
- Folate/B12 status indicators: folate (nmol/L), methylmalonic acid (umol/L) and cobalamin (pmol/L)
- Trace element status indicators: selenium (ug/L), copper (ug/L) and thyroglobulin (ug/L).
- The usefulness of a microsampler device to collect blood samples for future micronutrient assessments.
- Assessment and contrast of AMR gene abundances and diversity to develop resistomes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy infants | No intervention | – |
| Infants with an inflammatory condition | Experimental | Biological: Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).Investigators will also use pentavalent (PENTA) vaccine as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 9 - 18 months of age
- Infants with normal body temperature and normal CRP (<5 mg/L)
- Infants receive breast milk from the mother at least once per day
- Mothers produce a breast milk containing 30-40 nmol vitamin A /g milk fat
- Infants received a high-dose vitamin A capsules at the time of the most recent national distribution campaign (within the last 2-4 months)
Key exclusion criteria (5 listed)
- Mother or infant has chronic disease
- Mother or infant has acute illness on the day of data collection
- Infant is anemic (Hb <90 g/L)
- Infant has weight for length <80% of the reference median
- Infants do not develop inflammation (CRP ≥5 mg/L) after PENTA vaccination
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 |
|---|---|---|
| Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).Pentavalent vaccine is being recommended to provide infants at 6wk, 10wk and 14wk of age. This vaccine also induces plasma CRP >5 mg/L in infants within 24 hours of immunization. | Biological | Infants with an inflammatory condition |
Primary outcome
Inflammation marker C-reactive protein (CRP) levels in infants before and 1-day after inflammation
Time frame: 24 hours
In infants (9-18 mo) plasma CRP levels (mg/L) will be estimated by ELISA before and 24 hours after inflammation. Paired t-test will be used to evaluate the difference.
Vitamin A status in infants before and 1-day after inflammation
Time frame: 24 hours
In infants (9-18 mo) plasma retinol levels (nmol/L) will be estimated by HPLC before and 24 hours after inflammation.Paired t-test will be used to evaluate the difference.
Total body stores (TBS) of vitamin A in infants before and 1-day after inflammation
Time frame: 24 hours
In infants (9-18 mo) TBS of vitamin A (nmol) will be estimated before and 24 hours after inflammation. TBS will be measured by calculating the specific activities of 13C10- and 13C4- retinyl acetate in the blood samples by using liquid chromatography-tandem mass spectrometry (LC/MS/MS) method. Paired t-test will be used to evaluate the difference.
Iron status in infants before and 1-day after inflammation
Time frame: 24 hours
In infants (9-18 mo) plasma ferritin levels (ug/L) will be estimated by ELISA before and 24 hours after inflammation. Paired t-test will be used to evaluate the difference.
Iron status in infants before and 1-day after inflammation
Time frame: 24 hours
In infants (9-18 mo) plasma soluble transferrin receptor (sTfR) concentration (mg/L) will be estimated by ELISA before and 24 hours after inflammation. Paired t-test will be used to evaluate the difference.
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 26 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). in people with Healthy Infants, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
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 7 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. 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?
Inflammation marker C-reactive protein (CRP) levels in infants before and 1-day after inflammation (time frame: 24 hours). The study lists 5 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 26 Aug 2019.