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Timing of Iron Supplementation in Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT00683527
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : May 23, 2008
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Study Description
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.

Condition or disease Intervention/treatment
Nutritional Status Drug: Elemental iron

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial
Study Start Date : May 2006
Primary Completion Date : November 2006
Study Completion Date : January 2007

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Starting oral iron at day 14 of life (Early Iron group)
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
Other Name: 'Tonoferon' drops, East India Co
No Intervention: 2
No iron supplementation till 60 days of life (Control group)


Outcome Measures

Primary Outcome Measures :
  1. Serum ferritin [ Time Frame: 60 days postnatal age ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Till the end of study period (2 months) ]
  2. Hematologic and anthropometric parameters [ Time Frame: at 60 days of age ]
  3. Requirement of blood transfusion [ Time Frame: till the end of study period ]

Eligibility Criteria

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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT00683527


Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi (UT), India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Indian Council of Medical Research
Investigators
Principal Investigator: M Jeeva Sankar, MD DM All India Institute of Medical Sciences, New Delhi
Study Chair: Vinod K Paul, MD PhD All India Institute of Medical Sciences, New Delhi
Study Chair: Ramesh Agarwal, MD DM All India Institute of Medical Sciences, New Delhi
More Information

Responsible Party: M Jeeva Sankar, Department of Pediatrics, AIIMS, New Delhi
ClinicalTrials.gov Identifier: NCT00683527     History of Changes
Other Study ID Numbers: A-34/2006
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Iron supplementation
Timing
Serum ferritin
Very low birth weight infants

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs