NCT00683527

Brief Summary

To examine if early iron supplementation (starting oral iron at 14 days of life) would improve the nutritional iron status(measured by serum ferritin) of very low birth weight infants at postnatal age of 60 days, when compared to the standard regime of starting iron at 2 months of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

May 21, 2008

Last Update Submit

May 21, 2008

Conditions

Nutritional Status

Keywords

Iron supplementationTimingSerum ferritinVery low birth weight infants

Outcome Measures

Primary Outcomes (1)

  • Serum ferritin

    60 days postnatal age

Secondary Outcomes (3)

  • Composite outcome of neonatal morbidities that include chronic lung disease [CLD], necrotizing enterocolitis [NEC-any stage], periventricular leucomalacia [PVL], and retinopathy of prematurity [ROP] requiring treatment

    Till the end of study period (2 months)

  • Hematologic and anthropometric parameters

    at 60 days of age

  • Requirement of blood transfusion

    till the end of study period

Study Arms (2)

1

EXPERIMENTAL

Starting oral iron at day 14 of life (Early Iron group)

Drug: Elemental iron

2

NO INTERVENTION

No iron supplementation till 60 days of life (Control group)

Interventions

Elemental ironDRUG

Iron in the dose of 3-4 mg/kg/day (of elemental iron) PO once daily mixed with expressed breast milk from 14 days of life till the end of study period

Also known as: 'Tonoferon' drops, East India Co
1

Eligibility Criteria

Age14 Days - 60 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants who have reached at least 100 ml/kg/day of oral feeds by day 14 of life

You may not qualify if:

  • Major congenital anomalies
  • Rh hemolytic disease
  • Twin-to-twin transfusion syndrome
  • Refusal to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, Delhi (UT), 110029, India

Location

Study Officials

  • M Jeeva Sankar, MD DM

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Vinod K Paul, MD PhD

    All India Institute of Medical Sciences

    STUDY CHAIR

  • Ramesh Agarwal, MD DM

    All India Institute of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

May 1, 2006

Primary Completion

November 1, 2006

Study Completion

January 1, 2007

Last Updated

May 23, 2008

Record last verified: 2008-05

Locations

IN(1)