Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01125163
First received: May 13, 2010
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted post-menstrual age (or at discharge if sooner)?


Condition Intervention
Iron Deficiency Anemia
Dietary Supplement: Iron Supplement
Dietary Supplement: multivitamin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Trial Comparing Iron Supplementation vs. Routine Iron Intake in Very Low Birth Weight (VLBW) Infants

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Hematocrit Levels [ Time Frame: at 36 weeks adjusted post-menstrual age ] [ Designated as safety issue: No ]
    Hematocrit at 36 weeks adjusted post-menstrual age, or discharge if the infant is discharged sooner, will be analyzed as the primary outcome.


Secondary Outcome Measures:
  • Number of red cell transfusions after enrollment [ Time Frame: from study day 1 to 36 week adjusted post-menstrual age or discharge if the infant is discharged sooner ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: multivitamin with iron
daily oral multivitamin providing 2mg/kg of iron
Dietary Supplement: Iron Supplement
multivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120cc/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted post-menstrual age.
Other Name: iron supplementation
Placebo Comparator: multivitamin without iron
daily oral multivitamin without iron
Dietary Supplement: multivitamin
daily oral multivitamin without iron until 36 weeks adjusted post-menstrual age
Other Name: Multivitamin without iron

  Eligibility

Ages Eligible for Study:   24 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Birth weight <1500 grams
  • Tolerating iron fortified preterm formula or fortified human milk at 120cc/kg/day by 8 weeks of age
  • </= 32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

  • Cyanotic heart disease
  • Bowel resection prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125163

Contacts
Contact: Tiffany Taylor, M.D. 713-790-1135 tiffany.a.boone@uth.tmc.edu

Locations
United States, Texas
Children's Memorial Hermann Hospital, Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Tiffany Taylor, M.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Tiffany Taylor, M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided by The University of Texas Health Science Center, Houston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Tiffany Taylor, M.D., The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01125163     History of Changes
Other Study ID Numbers: HSC-MS-10-0031
Study First Received: May 13, 2010
Last Updated: November 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
very low birth weight infants
anemia
iron supplementation

Additional relevant MeSH terms:
Birth Weight
Anemia, Iron-Deficiency
Body Weight
Signs and Symptoms
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014