Iron Deficiency AnemiaNCT03534089
Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
A study testing Standard infant fomula, Low level LF infant formula and High level LF infant formula in people with Iron Deficiency Anemia, run by Beingmate Baby & Child Food Co Ltd . at 1 site in China.
Trial summary
A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and different contents lactoferrin. Read more about this study
- Who is it for?
- Ages 5 to 9 months
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Standard infant fomula, Low level LF infant formula and High level LF infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 31 Oct 2017
- 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 5 to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full term,healthy infants at 37-42 weeks of gestational age
- 5-9 months old infants were diagnose as iron deficiency anemia
- Accepting bottle feeding
Who cannot join
- Hb<60 g/L
- Other microcytic, hypochromic anemia
Trial locations and contacts
1 site in 1 country.
About this study
A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and different contents lactoferrin.
Read the detailed description
5-9 months old infants with iron deficiency anemia were randomly divided into three groups. On the basis of giving the same dose of ferralia,three different levels lactoferrin infant formula were intervened 3 months respectively,and evaluate the clinical effect.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Standard infant fomula, Low level LF infant formula, High level LF infant formula
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard infant fomulaOther
Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula without lactoferrin supplementation.
Low level LF infant formulaOther
Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula supplemented with low level of lactoferrin (38mg/100g).
High level LF infant formulaOther
Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula middle supplemented with high level of lactoferrin (76mg/100g).
| Study group | Role | What they receive |
|---|---|---|
| Standard infant fomula | Placebo comparator | Infants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with standard infant formula (without lactoferrin supplementation) Receives: Other: Standard infant fomula |
| Low level LF infant formula group | Experimental | Infants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with infant formula supplemented with low level of lactoferrin (38mg/100g). Lactoferrin:38mg/100g Receives: Other: Low level LF infant formula |
| High level LF infant formula group | Experimental | Infants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with infant formula supplemented with high level of lactoferrin (76mg/100g) Receives: Other: High level LF infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Hb concentration(g/L)
Hb was measured by the hemoglobincyanide method
Measured: Change of Hb concentration from baseline at 1 month and 3 months.
Secondary outcomes (5)
Change of body weight (kilograms)
Body weight is detected by electronic scale
Measured: Changes of body weight from baseline at 1 month and 3 months.
Change of body length (meters)
Body length is detected by infant height bed
Measured: Changes of body weight from baseline at 1 month and 3 months.
Change of head circumference (millimeters)
Head circumference detected by measuring tape
Measured: Changes of body weight from baseline at 1 month and 3 months.
Change of serum ferritin concentration (μg/L)
concentrations of serum ferritin (SF,μg/L) were measured using a commercial enzyme-linked immunosorbent assay (ELISA; Sunbiote, Shanghai, China).
Measured: Changes of serum iron concentration from baseline at 3 months.
Change of serum transferrin receptor concentration(mg/L)
Serum soluble transferrin receptor (sTfR, mg/L) was measured by microparticle-enhanced immunoassay (Sunbiote, Shanghai, China)
Measured: Changes of serum transferrin receptor concentration from baseline at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Feb 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beingmate Baby & Child Food Co Ltd .
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534089
- Sponsor's protocol ID
- RD07316001A
- Status last verified
- Dec 2017
- First submitted
- 27 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
- ClinicalTrials.gov ID
- NCT03534089
- Acronym / sponsor ID
- RD07316001A
- Conditions
- Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Beingmate Baby & Child Food Co Ltd .University, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 23 May 2018 (actual)
- 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.
A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and different contents lactoferrin.
Detailed description
5-9 months old infants with iron deficiency anemia were randomly divided into three groups. On the basis of giving the same dose of ferralia,three different levels lactoferrin infant formula were intervened 3 months respectively,and evaluate the clinical effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard infant fomula | Placebo comparator | Other: Standard infant fomulaInfants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with standard infant formula (without lactoferrin supplementation) |
| Low level LF infant formula group | Experimental | Other: Low level LF infant formulaInfants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with infant formula supplemented with low level of lactoferrin (38mg/100g). Lactoferrin:38mg/100g |
| High level LF infant formula group | Experimental | Other: High level LF infant formulaInfants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with infant formula supplemented with high level of lactoferrin (76mg/100g) |
Who may qualify
- Ages
- 5 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full term,healthy infants at 37-42 weeks of gestational age
- 5-9 months old infants were diagnose as iron deficiency anemia
- Accepting bottle feeding
Key exclusion criteria (2 listed)
- Hb<60 g/L
- Other microcytic, hypochromic anemia
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 |
|---|---|---|
| Standard infant fomulaInfants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula without lactoferrin supplementation. | Other | Standard infant fomula |
| Low level LF infant formulaInfants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula supplemented with low level of lactoferrin (38mg/100g). | Other | Low level LF infant formula group |
| High level LF infant formulaInfants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula middle supplemented with high level of lactoferrin (76mg/100g). | Other | High level LF infant formula group |
Primary outcome
Changes of Hb concentration(g/L)
Time frame: Change of Hb concentration from baseline at 1 month and 3 months.
Hb was measured by the hemoglobincyanide method
5 secondary outcomes
Change of body weight (kilograms)
Time frame: Changes of body weight from baseline at 1 month and 3 months.
Change of body length (meters)
Time frame: Changes of body weight from baseline at 1 month and 3 months.
Change of head circumference (millimeters)
Time frame: Changes of body weight from baseline at 1 month and 3 months.
Change of serum ferritin concentration (μg/L)
Time frame: Changes of serum iron concentration from baseline at 3 months.
Change of serum transferrin receptor concentration(mg/L)
Time frame: Changes of serum transferrin receptor concentration from baseline at 3 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 23 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard infant fomula, Low level LF infant formula and High level LF infant formula in people with Iron Deficiency Anemia, run by Beingmate Baby & Child Food Co Ltd . at 1 site in China.
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 23 May 2018. 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 China. 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?
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?
Changes of Hb concentration(g/L) (time frame: Change of Hb concentration from baseline at 1 month and 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2018.