Latent Iron DeficiencyNCT00554814
Interest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron Deficiency
A study testing Bledilait Biofer®, Milk supplemented with ferrous sulphate and Blédilait Biofer® in people with Latent Iron Deficiency, run by Bledina at 1 site in France.
Trial summary
The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Latent Iron Deficiency
- What is being tested?
- Bledilait Biofer®, Milk supplemented with ferrous sulphate and Blédilait Biofer®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Dec 2008
- 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
- infant between 6 and 12 months of age,
- preterm infant, low birth weight infant (< 2,5 kg), multiple pregnancy, infant from mother with close pregnancies (2 babies in 2 years),
- infant with a serum ferritin value < 12ng/ml and with a normal haemoglobin value (> 11 g/dl), i.e. with a latent iron deficiency,
- infant whose parents or legal tutors have given written informed consent,
- parents or legal tutors agreeing for 4 month follow-up by the investigator,
- infant for which a clinical exam has been performed,
- infant with health insurance.
Who cannot join
- infant with serum ferritin value < 12 ng/ml and haemoglobin value < 11 g/dl
- infant already receiving medicinal iron supplementation,
- infant with acquired or congenital defect,
- infant presenting a significant metabolic, organic or digestive disease able to interfere with study (including hemochromatosis)
- infant with congenital and/or chromosomal malformation
- infant receiving a drug susceptible, according to the investigator, to interfere with the measured study parameters
- infant needing specific infant formula (hypoallergenic, without cow milk proteins)
- infant in a situation that could, according to investigator, interfere with an optimal participation to the study or be a health risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Biofer ® Compound Used in Blédilait Follow on Milk and Growing Milk on Iron Status Evolution in Infant With Latent Iron Deficiency
The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks.
- Conditions
- Latent Iron Deficiency
- Being tested
- Bledilait Biofer®, Milk supplemented with ferrous sulphate, Blédilait Biofer®
- Keywords
- Iron deficiency, Ferritin, Encapsulated iron, Infant formula
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bledilait Biofer®Drug
Bledilait Biofer® 2 mg/100 kcal
Milk supplemented with ferrous sulphateDrug
Milk supplemented with ferrous sulphate (2mg/100kcal)
Blédilait Biofer®Drug
Blédilait Biofer® milk (1,1mg/100kcal)
| Study group | Role | What they receive |
|---|---|---|
| 3 | Experimental | Blédilait Biofer® milk (1,1mg/100kcal) Receives: Drug: Blédilait Biofer® |
| 1 | Experimental | Blédilait Biofer® milk (2mg/100kcal) Receives: Drug: Bledilait Biofer® |
| 2 | Active comparator | Milk supplemented with ferrous sulphate (2mg/100kcal) Receives: Drug: Milk supplemented with ferrous sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin value measured after 2 months of studied milks consumption.
Measured: 2 months
Secondary outcomes (1)
- Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption
Measured: baseline, baseline + 2 months, baseline + 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2008 (estimated)
- Study completionDec 2008 (estimated)
Why it stopped: insufficient recruitment
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 Latent Iron DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bledina
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacques LANGUE, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554814
- Sponsor's protocol ID
- BL010
- Other IDs
- N° ID RCB : 2007-A00684-49
- Status last verified
- Nov 2008
- First submitted
- 6 Nov 2007
- Last updated
- 17 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rughwani H, Singh AP, Ramchandani M, Jagtap N, Pal P, Inavolu P, Reddy PM, Januszewicz W, Sekaran A, Nabi Z, Patel R, Lakhtakia S, Banerjee R, Memon SF, Balram P, Darishetty S, Rao GV, Reddy DN. A Randomized, Controlled Trial Comparing the Total Enteroscopy Rate and Diagnostic Efficacy of Novel Motorized Spiral Enteroscopy and Single-Balloon Enteroscopy in Patients With Small-Bowel Disorders: The Motor Trial (NCT 05548140). Am J Gastroenterol. 2023 Oct 1;118(10):1855-1863. doi: 10.14309/ajg.0000000000002409. Epub 2023 Jul 19.
PubMed 37463435
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Biofer ® Compound Used in Blédilait Follow on Milk and Growing Milk on Iron Status Evolution in Infant With Latent Iron Deficiency
- ClinicalTrials.gov ID
- NCT00554814
- Acronym / sponsor ID
- BL010
- Conditions
- Latent Iron Deficiency
- Keywords
- Iron deficiency, Ferritin, Encapsulated iron, Infant formula
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: insufficient recruitment
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- BledinaIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 7 Nov 2007 (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 primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Experimental | Drug: Blédilait Biofer®Blédilait Biofer® milk (1,1mg/100kcal) |
| 1 | Experimental | Drug: Bledilait Biofer®Blédilait Biofer® milk (2mg/100kcal) |
| 2 | Active comparator | Drug: Milk supplemented with ferrous sulphateMilk supplemented with ferrous sulphate (2mg/100kcal) |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- infant between 6 and 12 months of age,
- preterm infant, low birth weight infant (< 2,5 kg), multiple pregnancy, infant from mother with close pregnancies (2 babies in 2 years),
- infant with a serum ferritin value < 12ng/ml and with a normal haemoglobin value (> 11 g/dl), i.e. with a latent iron deficiency,
- infant whose parents or legal tutors have given written informed consent,
- parents or legal tutors agreeing for 4 month follow-up by the investigator,
Key exclusion criteria (8 listed)
- infant with serum ferritin value < 12 ng/ml and haemoglobin value < 11 g/dl
- infant already receiving medicinal iron supplementation,
- infant with acquired or congenital defect,
- infant presenting a significant metabolic, organic or digestive disease able to interfere with study (including hemochromatosis)
- infant with congenital and/or chromosomal malformation
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 |
|---|---|---|
| Bledilait Biofer®Bledilait Biofer® 2 mg/100 kcal | Drug | 1 |
| Milk supplemented with ferrous sulphateMilk supplemented with ferrous sulphate (2mg/100kcal) | Drug | 2 |
| Blédilait Biofer®Blédilait Biofer® milk (1,1mg/100kcal) | Drug | 3 |
Primary outcome
Serum ferritin value measured after 2 months of studied milks consumption.
Time frame: 2 months
1 secondary outcome
- Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption
Time frame: baseline, baseline + 2 months, baseline + 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2008.
- Derived from this study: PubMed 37463435Rughwani H, Singh AP, Ramchandani M, Jagtap N, Pal P, Inavolu P, Reddy PM, Januszewicz W, Sekaran A, Nabi Z, Patel R, Lakhtakia S, Banerjee R, Memon SF, Balram P, Darishetty S, Rao GV, Reddy DN. A Randomized, Controlled Trial Comparing the Total Enteroscopy Rate and Diagnostic Efficacy of Novel Motorized Spiral Enteroscopy and Single-Balloon Enteroscopy in Patients With Small-Bowel Disorders: The Motor Trial (NCT 05548140). Am J Gastroenterol. 2023 Oct 1;118(10):1855-1863. doi: 10.14309/ajg.0000000000002409. Epub 2023 Jul 19.
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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.
Jacques LANGUE principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bledilait Biofer®, Milk supplemented with ferrous sulphate and Blédilait Biofer® in people with Latent Iron Deficiency, run by Bledina at 1 site in France.
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 7 inclusion and 8 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: paused, as of the sponsor's last update on 17 Nov 2008. 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 France. 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?
Results are not available in the source record.
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?
Serum ferritin value measured after 2 months of studied milks consumption. (time frame: 2 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 NCT00554814, 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 17 Nov 2008.