Influence of Inflammation on Micronutrient Status Assessment
1 other identifier
interventional
75
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 26, 2019
September 1, 2018
10 months
March 29, 2018
August 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
24 hours
Study Arms (2)
Healthy infants
NO INTERVENTIONInfants with an inflammatory condition
EXPERIMENTALInvestigators 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)).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clinical Trail Unit (CTU), icddr,b.
Dhaka, 1212, Bangladesh
Shaikh M Ahmad
Dhaka, 1212, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2018
First Posted
January 11, 2019
Study Start
June 1, 2018
Primary Completion
March 31, 2019
Study Completion
June 30, 2019
Last Updated
August 26, 2019
Record last verified: 2018-09