Iron Deficiency AnemiaNCT00998998
The Anemia Control Program: Early Intervention
A study testing Home stimulation, Surveillance and Iron in people with Iron Deficiency Anemia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in Chile.
Trial summary
The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Home stimulation, Surveillance and Iron
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteChile
- Study dates
- Apr 1992to Jul 1996
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight >= 3.0kg
- singleton full-term birth
- routine vaginal delivery
- no major congenital anomalies
- no major perinatal complications
- no photo therapy
Show all 12Show fewer
- no hospitalization for longer than 5 days
- no chronic illness
- no iron therapy
- from 1991-94, infants on >= 250 ml/day cow milk or formula
- from 1994-96, infants could be on < 250 ml/day cow milk or formula
- infants identified as anemic at 6 or 12 months and randomly selected nonanemic infants at 6 and 12 months
Who cannot join
- residence outside 4 contiguous working-class communities on outskirts of Santiago, Chile
- another infant <12 months in household
- infant in child care
- illiterate or psychotic caregiver or no stable caregiver available to accompany the child for appointments.
- until mid-1994, "exclusive" breastfeeding, defined as >250 mL/d cow milk or formula
Trial locations and contacts
1 site in 1 country.
Chile1 site
Instituto de Nutrición y Tecnología de los Alimentos (INTA)
Santiago
About this study
Official title: Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II
The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA.
Read the detailed description
Iron-deficiency anemia (IDA) is associated with alterations in infant behavior and development that may not correct with iron therapy. The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA. IDA and non-anemic infants were randomly assigned to a year of intervention or surveillance only. Infants were enrolled and began study participation at 6 or 12 months. All infants were treated with oral iron and visited weekly to record iron intake, feeding, and health (surveillance). For infants randomized to intervention, the weekly home visit included an hour-long program fostering child development by supporting the mother-infant relationship. Psychologists, unaware of iron status or intervention assignment, assessed cognitive, motor, and social-emotional development (Bayley Scales) at the beginning, midpoint, and end of the year.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Home stimulation, Surveillance, Iron
- Keywords
- iron deficiency anemia, infant behavior, infant development
- Medical subject headings
- Anemia, Iron-Deficiency, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home stimulationBehavioural
Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
SurveillanceBehavioural
Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.
IronDietary supplement
Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6 or 12 month old infants with iron deficiency anemia assigned to receive home stimulation program via weekly home visits over 1 year Receives: Behavioral: Home stimulation; Dietary Supplement: Iron |
| 2 | Active comparator | 6 or 12 month old infants with iron deficiency anemia assigned to surveillance (weekly visits to monitor health and iron supplement) over 1 year Receives: Behavioral: Surveillance; Dietary Supplement: Iron |
| 3 | Experimental | Nonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year Receives: Behavioral: Home stimulation; Dietary Supplement: Iron |
| 4 | Active comparator | Nonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year Receives: Behavioral: Surveillance; Dietary Supplement: Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant behavior and development
Measured: 6, 12, and 18 months; or 12, 18, and 24 months
Secondary outcomes (1)
Iron-deficiency anemia
Measured: 6, 12, and 18 months; or 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startApr 1992
- Primary completionJul 1996
- Study completionJul 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Betsy Lozoff, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998998
- Sponsor's protocol ID
- R01HD014122
- Status last verified
- Jun 2010
- First submitted
- 20 Oct 2009
- Last updated
- 21 Jul 2010
- Results posted
- No
Publications
Lozoff B, Smith JB, Clark KM, Perales CG, Rivera F, Castillo M. Home intervention improves cognitive and social-emotional scores in iron-deficient anemic infants. Pediatrics. 2010 Oct;126(4):e884-94. doi: 10.1542/peds.2009-3535. Epub 2010 Sep 20.
PubMed 20855384
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II
- ClinicalTrials.gov ID
- NCT00998998
- Acronym / sponsor ID
- R01HD014122
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency anemia, infant behavior, infant development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Apr 1992
- Primary completion
- Jul 1996 (actual)
- Study completion
- Jul 1996 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA.
Detailed description
Iron-deficiency anemia (IDA) is associated with alterations in infant behavior and development that may not correct with iron therapy. The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA. IDA and non-anemic infants were randomly assigned to a year of intervention or surveillance only. Infants were enrolled and began study participation at 6 or 12 months. All infants were treated with oral iron and visited weekly to record iron intake, feeding, and health (surveillance). For infants randomized to intervention, the weekly home visit included an hour-long program fostering child development by supporting the mother-infant relationship. Psychologists, unaware of iron status or intervention assignment, assessed cognitive, motor, and social-emotional development (Bayley Scales) at the beginning, midpoint, and end of the year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Home stimulation, Dietary Supplement: Iron6 or 12 month old infants with iron deficiency anemia assigned to receive home stimulation program via weekly home visits over 1 year |
| 2 | Active comparator | Behavioral: Surveillance, Dietary Supplement: Iron6 or 12 month old infants with iron deficiency anemia assigned to surveillance (weekly visits to monitor health and iron supplement) over 1 year |
| 3 | Experimental | Behavioral: Home stimulation, Dietary Supplement: IronNonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year |
| 4 | Active comparator | Behavioral: Surveillance, Dietary Supplement: IronNonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- birth weight >= 3.0kg
- singleton full-term birth
- routine vaginal delivery
- no major congenital anomalies
- no major perinatal complications
Key exclusion criteria (5 listed)
- residence outside 4 contiguous working-class communities on outskirts of Santiago, Chile
- another infant <12 months in household
- infant in child care
- illiterate or psychotic caregiver or no stable caregiver available to accompany the child for appointments.
- until mid-1994, "exclusive" breastfeeding, defined as >250 mL/d cow milk or formula
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 |
|---|---|---|
| Home stimulationWeekly visit of one hour to the home over the course of one year to foster the mother-child relationship. | Behavioural | 1, 3 |
| SurveillanceWeekly visits to the home over the course of one year to record iron intake, feeding, and health information. | Behavioural | 2, 4 |
| IronSix-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d. | Dietary supplement | 1, 2, 3, 4 |
Primary outcome
Infant behavior and development
Time frame: 6, 12, and 18 months; or 12, 18, and 24 months
1 secondary outcome
Iron-deficiency anemia
Time frame: 6, 12, and 18 months; or 12, 18 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
- Derived from this study: PubMed 20855384Lozoff B, Smith JB, Clark KM, Perales CG, Rivera F, Castillo M. Home intervention improves cognitive and social-emotional scores in iron-deficient anemic infants. Pediatrics. 2010 Oct;126(4):e884-94. doi: 10.1542/peds.2009-3535. Epub 2010 Sep 20.
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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.
Betsy Lozoff, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home stimulation, Surveillance and Iron in people with Iron Deficiency Anemia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in Chile.
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 12 inclusion and 5 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 21 Jul 2010. 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 Chile. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infant behavior and development (time frame: 6, 12, and 18 months; or 12, 18, and 24 months). 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 NCT00998998, 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 21 Jul 2010.