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Influence of Inflammation on Micronutrient Status Assessment

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ClinicalTrials.gov Identifier: NCT03801161
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Newcastle University, UK
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Infants 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)). Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Influence of Inflammation on Micronutrient Status Assessment
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Healthy infants
Experimental: Infants with an inflammatory condition
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)).
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)).
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   9 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. 9 - 18 months of age
  2. Infants with normal body temperature and normal CRP (<5 mg/L)
  3. Infants receive breast milk from the mother at least once per day
  4. Mothers produce a breast milk containing 30-40 nmol vitamin A /g milk fat
  5. Infants received a high-dose vitamin A capsules at the time of the most recent national distribution campaign (within the last 2-4 months)
  6. Mother is 18 - 45 years of age
  7. Mother and her infant plan to stay in the study area for the duration of the study

Exclusion criteria:

  1. Mother or infant has chronic disease
  2. Mother or infant has acute illness on the day of data collection
  3. Infant is anemic (Hb <90 g/L)
  4. Infant has weight for length <80% of the reference median
  5. Infants do not develop inflammation (CRP ≥5 mg/L) after PENTA vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801161


Contacts
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Contact: Shaikh M Ahmad, Ph.D. 8860523-32 ext 2404 smeahmad@icddrb.org
Contact: Rubhana Raqib, Ph.D. 8860523-32 ext 2404 rubhana@icddrb.org

Locations
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Bangladesh
Clinical Trail Unit (CTU), icddr,b. Recruiting
Dhaka, Bangladesh, 1212
Contact: Rubhana Raqib, Ph.D.    8860523-32 ext 2415    rubhana@icddrb.org   
Shaikh M Ahmad Recruiting
Dhaka, Bangladesh, 1212
Contact: Shaikh M Ahmad, Ph. D.    8860523-32 ext 2413    smeahmad@icddrb.org   
Principal Investigator: Shaikh M Ahmad, Ph. D.         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Newcastle University, UK

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03801161     History of Changes
Other Study ID Numbers: PR-18006
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
vitamin A
vitamin A isotope
vitamin D
ferritin
transferrin receptor
folate
cobalamin
beta-carotene
Inflammation

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Vaccines
Vitamin A
Micronutrients
Trace Elements
Immunologic Factors
Physiological Effects of Drugs
Vitamins
Nutrients
Growth Substances