AnemiaPhase 3NCT00136266
Adherence With Iron Sprinkles Among High-Risk Infants
A Phase 3 study testing Ferrous sulphate drops with vitamins A, D, and C and Ferrous fumarate sprinkles with vitamins and minerals in people with Anemia and Iron Deficiency, run by Centers for Disease Control and Prevention at 2 sites in United States.
Trial summary
Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency. Read more about this study
- Who is it for?
- Ages 5 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- Ferrous sulphate drops with vitamins A, D, and C and Ferrous fumarate sprinkles with vitamins and minerals
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Dec 2005
- Phase
- Phase 3
- 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 5 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants
- Age 5-7 months
- Presenting for 6 months well-child care
- Caregiver speaks English or Spanish
Who cannot join
- Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)
- Inability to speak English or Spanish
- Use of vitamin or iron supplements in the previous three months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Whittier Street Health Center
Boston, Massachusetts, 02108
Boston Medical Center Pediatric Primary Care Clinic
Boston, Massachusetts, 02118
About this study
Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.
Read the detailed description
Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.
Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.
- Conditions
- Anemia, Iron Deficiency
- Being tested
- Ferrous sulphate drops with vitamins A, D, and C, Ferrous fumarate sprinkles with vitamins and minerals
- Keywords
- Adherence, Supplements, Iron, Iron deficiency, Anemia, Vitamins, Minerals
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulphate drops with vitamins A, D, and CDrug
Ferrous fumarate sprinkles with vitamins and mineralsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
full adherence, use of iron supplements 6-7 days/week for 3 months
Secondary outcomes (2)
iron deficiency at 9 months of age
anemia at 9 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Paul L. Geltman, MD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136266
- Sponsor's protocol ID
- CDC-NCCDPHP-MM-0835-O5/05
- Other IDs
- CDC-MM-0835-O5/05
- Status last verified
- Sep 2007
- First submitted
- 25 Aug 2005
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Geltman PL, Hironaka LK, Mehta SD, Padilla P, Rodrigues P, Meyers AF, Bauchner H. Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops. J Pediatr. 2009 May;154(5):738-43. doi: 10.1016/j.jpeds.2008.11.003. Epub 2008 Dec 25.
PubMed 19111318
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence With Iron Sprinkles Among High-Risk Infants
- ClinicalTrials.gov ID
- NCT00136266
- Acronym / sponsor ID
- CDC-NCCDPHP-MM-0835-O5/05
- Conditions
- Anemia, Iron Deficiency
- Keywords
- Adherence, Supplements, Iron, Iron deficiency, Anemia, Vitamins, Minerals
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 29 Aug 2005 (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.
Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.
Detailed description
Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.
Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants
- Age 5-7 months
- Presenting for 6 months well-child care
- Caregiver speaks English or Spanish
Key exclusion criteria (3 listed)
- Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)
- Inability to speak English or Spanish
- Use of vitamin or iron supplements in the previous three months
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 |
|---|---|---|
| Ferrous sulphate drops with vitamins A, D, and C | Drug | – |
| Ferrous fumarate sprinkles with vitamins and minerals | Drug | – |
Primary outcome
full adherence, use of iron supplements 6-7 days/week for 3 months
2 secondary outcomes
iron deficiency at 9 months of age
anemia at 9 months of age
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 3 Feb 2016.
- Results publication: PubMed 19111318Geltman PL, Hironaka LK, Mehta SD, Padilla P, Rodrigues P, Meyers AF, Bauchner H. Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops. J Pediatr. 2009 May;154(5):738-43. doi: 10.1016/j.jpeds.2008.11.003. Epub 2008 Dec 25.
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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.
Paul L. Geltman, MD, MPH principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrous sulphate drops with vitamins A, D, and C and Ferrous fumarate sprinkles with vitamins and minerals in people with Anemia and Iron Deficiency, run by Centers for Disease Control and Prevention at 2 sites 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 4 inclusion and 3 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 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
full adherence, use of iron supplements 6-7 days/week for 3 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 NCT00136266, 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 3 Feb 2016.