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to Assess the Effect of Early vs Routine Iron Supplementation on Iron Store and Growth in Term Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03171324
Recruitment Status : Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
Deepanjan Bhattacharya, Postgraduate Institute of Medical Education and Research

Brief Summary:
Term infants (Small for Gestational Age and Appropriate for Gestational Age) would be randomized to receive oral iron supplementation from 6 weeks and 6 months. Growth in terms of Occipitofrontal circumference, length and weight would be monitored at 6 weeks, 6 months and 1 year of age. Hemoglobin, RBC (Red blood corpuscles) indices and ferritin would be monitored at 6 months and 1 year of age.

Condition or disease Intervention/treatment Phase
Iron-deficiency Drug: Iron Supplement Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: a Randomized Control Trial to Assess the Effect of Early vs Routine Iron Supplementation on Iron Store and Growth in Term Small for Gestational Age and Appropriate for Gestational Age Infants at 1 Year
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: AGA 6 weeks
Iron supplementation will be started at 2mg/kg from 6 weeks of age to 1 year
Drug: Iron Supplement
2 mg/kg/day elemental iron
Other Name: Tonoferon

Experimental: AGA 6 months
Iron supplementation will be started from 6 months of age to 1 year
Drug: Iron Supplement
2 mg/kg/day elemental iron
Other Name: Tonoferon

Experimental: SGA 6 weeks
Iron supplementation will be started from 6 weeks of age to 1 year
Drug: Iron Supplement
2 mg/kg/day elemental iron
Other Name: Tonoferon

Experimental: SGA 6 months
Iron supplementation will be started from 6 months of age to 1 year
Drug: Iron Supplement
2 mg/kg/day elemental iron
Other Name: Tonoferon




Primary Outcome Measures :
  1. Iron deficiency anemia [ Time Frame: 1 year ]
    Hemoglobin


Secondary Outcome Measures :
  1. Growth parameter1 [ Time Frame: 6 months ]
    Occipitofrontal circumference (OFC) in cm at 6 months

  2. Growth parameter2 [ Time Frame: 6 months ]
    Length (in cm) at 6 months

  3. Growth parameter3 [ Time Frame: 6 months ]
    Weight (in kg) at 6 months

  4. Iron stores [ Time Frame: 6 months ]
    iron stores will be evaluated by ferritin, and anemia evaluated by hemoglobin

  5. Growth parameter4 [ Time Frame: 1 year ]
    OccipitoFrontal Circumference (in cm) at 1 year of age.

  6. Growth parameter5 [ Time Frame: 1 year ]
    Length (in cm) at 1 year of age.

  7. Growth parameter6 [ Time Frame: 1 year ]
    Weight (in kg) at 1 year of age.

  8. Iron stores [ Time Frame: 1 year ]
    iron stores will be evaluated by ferritin at 1 year of age, along with hemoglobin



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Ages Eligible for Study:   6 Weeks to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term infants (born after 37 completed weeks of gestation by USG dating or LMP and postnatally by New ballard scoring whichever applicable)
  • Appropriate for gestational age (as per revised Fenton's chart 2013)
  • Small for gestational age (birth weight <10th percentile as per revised Fenton's chart 2013) - Parents consenting to follow up till 1 year
  • Parents residing within 100 kilometres of Chandigarh

Exclusion Criteria:

  1. H/o blood product transfusion prior to study enrolment
  2. Neonatal jaundice due to hemolytic anemia
  3. Severe birth asphyxia defined as 1 minute Apgar score 0-3 with or without moderate to severe HIE (Hypoxic Ischemic Encephalopathy).
  4. Severe sepsis with septic shock
  5. Suspect haematological disorders
  6. Infants with chronic diseases like congenital heart disease, cholestatic jaundice and suspected liver disease, suspected or diagnosed renal tubular acidosis, suspected or diagnosed inborn errors of metabolism
  7. Suspected or proven chromosomal abnormalities.

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): NCT03171324


Locations
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India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Deepanjan Bhattacharya
Postgraduate Institute of Medical Education and Research
Investigators
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Study Director: Kanya Mukhopadhyay, MD DM Postgraduate Institute of Medical Education and Research

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Responsible Party: Deepanjan Bhattacharya, PRINCIPAL INVESTIGATOR Junior resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03171324    
Other Study ID Numbers: Deep1234
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not to be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs