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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00683527
Other study ID # A-34/2006
Secondary ID
Status Completed
Phase N/A
First received May 21, 2008
Last updated May 21, 2008
Start date May 2006
Est. completion date January 2007

Study information

Verified date May 2008
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date January 2007
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 60 Days
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
India All India Institute of Medical Sciences New Delhi Delhi (UT)

Sponsors (2)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum ferritin 60 days postnatal age No
Secondary 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) Yes
Secondary Hematologic and anthropometric parameters at 60 days of age No
Secondary Requirement of blood transfusion till the end of study period No
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