NCT03171324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

February 26, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

February 26, 2017

Last Update Submit

August 28, 2018

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

  • Iron deficiency anemia

    Hemoglobin

    1 year

Secondary Outcomes (8)

  • Growth parameter1

    6 months

  • Growth parameter2

    6 months

  • Growth parameter3

    6 months

  • Iron stores

    6 months

  • Growth parameter4

    1 year

  • +3 more secondary outcomes

Study Arms (4)

AGA 6 weeks

EXPERIMENTAL

Iron supplementation will be started at 2mg/kg from 6 weeks of age to 1 year

Drug: Iron Supplement

AGA 6 months

EXPERIMENTAL

Iron supplementation will be started from 6 months of age to 1 year

Drug: Iron Supplement

SGA 6 weeks

EXPERIMENTAL

Iron supplementation will be started from 6 weeks of age to 1 year

Drug: Iron Supplement

SGA 6 months

EXPERIMENTAL

Iron supplementation will be started from 6 months of age to 1 year

Drug: Iron Supplement

Interventions

Iron SupplementDRUG

2 mg/kg/day elemental iron

Also known as: Tonoferon
AGA 6 monthsAGA 6 weeksSGA 6 monthsSGA 6 weeks

Eligibility Criteria

Age6 Weeks - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • H/o blood product transfusion prior to study enrolment
  • Neonatal jaundice due to hemolytic anemia
  • Severe birth asphyxia defined as 1 minute Apgar score 0-3 with or without moderate to severe HIE (Hypoxic Ischemic Encephalopathy).
  • Severe sepsis with septic shock
  • Suspect haematological disorders
  • 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
  • Suspected or proven chromosomal abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Kanya Mukhopadhyay, MD DM

    Post Graduate Institute of Medical Education and Research, Chandigarh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PRINCIPAL INVESTIGATOR Junior resident

Study Record Dates

First Submitted

February 26, 2017

First Posted

May 31, 2017

Study Start

March 1, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Not to be shared

Locations

IN(1)