MedDataX Logo

Interest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron Deficiency

NCT ID: NCT00554814

Last Updated: 2008-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Latent Iron Deficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Iron deficiency Ferritin Encapsulated iron Infant formula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3

Blédilait Biofer® milk (1,1mg/100kcal)

Group Type EXPERIMENTAL

Blédilait Biofer®

Intervention Type DRUG

Blédilait Biofer® milk (1,1mg/100kcal)

1

Blédilait Biofer® milk (2mg/100kcal)

Group Type EXPERIMENTAL

Bledilait Biofer®

Intervention Type DRUG

Bledilait Biofer® 2 mg/100 kcal

2

Milk supplemented with ferrous sulphate (2mg/100kcal)

Group Type ACTIVE_COMPARATOR

Milk supplemented with ferrous sulphate

Intervention Type DRUG

Milk supplemented with ferrous sulphate (2mg/100kcal)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bledilait Biofer®

Bledilait Biofer® 2 mg/100 kcal

Intervention Type DRUG

Milk supplemented with ferrous sulphate

Milk supplemented with ferrous sulphate (2mg/100kcal)

Intervention Type DRUG

Blédilait Biofer®

Blédilait Biofer® milk (1,1mg/100kcal)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bledina

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bledina

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jacques LANGUE

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alain BOCQUET

Besançon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37463435 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N° ID RCB : 2007-A00684-49

Identifier Type: -

Identifier Source: secondary_id

BL010

Identifier Type: -

Identifier Source: org_study_id