Iron Deficiency AnemiaNCT01125163
Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
A study testing Iron Supplement and multivitamin in people with Iron Deficiency Anemia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine 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 postmenstrual age (or at… Read more about this study
- Who is it for?
- Ages 24 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron Supplement and multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Cyanotic heart disease
- Bowel resection prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, 77030
About this study
Official title: Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine 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 postmenstrual age (or at discharge if sooner)?
Read the detailed description
Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron Supplement, multivitamin
- Keywords
- very low birth weight infants, anemia, iron supplementation
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SupplementDietary supplement
Also called iron supplementation
multivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120 ml/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted postmenstrual age.
multivitaminDietary supplement
Also called Multivitamin without iron
daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age
| Study group | Role | What they receive |
|---|---|---|
| multivitamin with iron | Active comparator | daily oral multivitamin providing 2mg/kg of iron Receives: Dietary Supplement: Iron Supplement |
| multivitamin without iron | Placebo comparator | daily oral multivitamin without iron Receives: Dietary Supplement: multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome.
Measured: at 36 weeks adjusted postmenstrual age
Secondary outcomes (1)
Number of Participants Who Received Red Cell Transfusions During Intervention Period
The numbers below represent the number of participants in each arm that received a transfusion during intervention period.
Measured: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Taylor, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125163
- Sponsor's protocol ID
- HSC-MS-10-0031
- Status last verified
- Jul 2018
- First submitted
- 13 May 2010
- Last updated
- 4 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Taylor TA, Kennedy KA. Randomized trial of iron supplementation versus routine iron intake in VLBW infants. Pediatrics. 2013 Feb;131(2):e433-8. doi: 10.1542/peds.2012-1822. Epub 2013 Jan 21.
PubMed 23339225
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01125163
- Acronym / sponsor ID
- HSC-MS-10-0031
- Conditions
- Iron Deficiency Anemia
- Keywords
- very low birth weight infants, anemia, iron supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Posted 4 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine 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 postmenstrual age (or at discharge if sooner)?
Detailed description
Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multivitamin with iron | Active comparator | Dietary Supplement: Iron Supplementdaily oral multivitamin providing 2mg/kg of iron |
| multivitamin without iron | Placebo comparator | Dietary Supplement: multivitamindaily oral multivitamin without iron |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cyanotic heart disease
- Bowel resection prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron SupplementAlso: iron supplementationmultivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120 ml/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted postmenstrual age. | Dietary supplement | multivitamin with iron |
| multivitaminAlso: Multivitamin without irondaily oral multivitamin without iron until 36 weeks adjusted postmenstrual age | Dietary supplement | multivitamin without iron |
Primary outcome
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
Time frame: at 36 weeks adjusted postmenstrual age
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome.
1 secondary outcome
Number of Participants Who Received Red Cell Transfusions During Intervention Period
Time frame: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23339225Taylor TA, Kennedy KA. Randomized trial of iron supplementation versus routine iron intake in VLBW infants. Pediatrics. 2013 Feb;131(2):e433-8. doi: 10.1542/peds.2012-1822. Epub 2013 Jan 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Taylor, M.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Supplement and multivitamin in people with Iron Deficiency Anemia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) (time frame: at 36 weeks adjusted postmenstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01125163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.