Influence of Inflammation on Micronutrient Status Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Iron status in infants before and 1-day after inflammation
Study Overview
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.
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:
I. 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 9 Months to 18 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Healthy infants
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)).
Intervention: 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)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported