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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01125163
First Posted: May 18, 2010
Last Update Posted: November 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The University of Texas Health Science Center, Houston
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: May 13, 2010
First Posted: May 18, 2010
Last Update Posted: November 30, 2010
Last Verified: November 2010

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

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