Status:

COMPLETED

Influence of Inflammation on Micronutrient Status Assessment

Lead Sponsor:

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborating Sponsors:

Newcastle University, UK

Conditions:

Healthy Infants

Eligibility:

All Genders

9-18 years

Phase:

NA

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 se...

Detailed Description

Background: Subclinical micronutrient deficiencies remain a hidden aspect of malnutrition for which comprehensive data are lacking. Defining subclinical micronutrient deficiencies requires considerin...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 30 2019

    Estimated Enrollment :

    75 Patients enrolled

    Trial Details

    Trial ID

    NCT03801161

    Start Date

    June 1 2018

    End Date

    June 30 2019

    Last Update

    August 26 2019

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Clinical Trail Unit (CTU), icddr,b.

    Dhaka, Bangladesh, 1212

    2

    Shaikh M Ahmad

    Dhaka, Bangladesh, 1212