Timing of Iron Supplementation in Very Low Birth Weight Infants

NCT ID: NCT00683527

Last Updated: 2008-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-01-31

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.

Detailed Description

Smaller the preterm infants at birth, more susceptible they are to iron deficiency due to low body iron stores. Despite having low iron stores, very low birth weight (VLBW) infants are not usually started on iron supplementation till they reach a postnatal age of 6 to 8 weeks. Such delayed supplementation can lead to rapid depletion of iron stores when erythropoiesis becomes active (by 8 weeks of life).

Depletion of iron stores is the first step in the continuum of changes that occur in iron deficiency. Iron deficiency induces biochemical defects (such as impaired synthesis of DNA and collagen) even before any features of microcytic, hypochromic anemia become evident. The rapidly maturing preterm brain is especially vulnerable to the effects of iron deficiency; poor school-age performance has been reported among children who had low iron stores in their neonatal period.

Early iron supplementation i.e. starting iron once the infant reaches full enteral feeds could potentially improve the iron stores and prevent its depletion. Surprisingly, few studies are available till date to support (or refute!) this view. The current study was designed to test the hypothesis whether early iron supplementation would increase the nutritional iron status (as measured by serum ferritin) at 60 days of life when compared to the existing regime of starting iron at the age 2 months.

Conditions

Nutritional Status

Keywords

Iron supplementation; Timing; Serum ferritin; Very low birth weight infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Elemental iron

Intervention Type: DRUG

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

2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Elemental iron

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

Intervention Type: DRUG

Other Intervention Names

'Tonoferon' drops, East India Co

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 60 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Department of Pediatrics, AIIMS, New Delhi

Principal Investigators

M Jeeva Sankar, MD DM

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Vinod K Paul, MD PhD

Role: STUDY_CHAIR

All India Institute of Medical Sciences

Ramesh Agarwal, MD DM

Role: STUDY_CHAIR

All India Institute of Medical Sciences

Locations

All India Institute of Medical Sciences

New Delhi, Delhi (UT), India

Countries

India

Other Identifiers

A-34/2006

Identifier Type: -

Identifier Source: org_study_id