NCT00554814

Brief 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 17, 2008

Status Verified

November 1, 2008

Enrollment Period

1 year

First QC Date

November 6, 2007

Last Update Submit

November 14, 2008

Conditions

Latent Iron Deficiency

Keywords

Iron deficiencyFerritinEncapsulated ironInfant formula

Outcome Measures

Primary Outcomes (1)

  • Serum ferritin value measured after 2 months of studied milks consumption.

    2 months

Secondary Outcomes (1)

  • - Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption

    baseline, baseline + 2 months, baseline + 4 months

Study Arms (3)

3

EXPERIMENTAL

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

Drug: Blédilait Biofer®

1

EXPERIMENTAL

Blédilait Biofer® milk (2mg/100kcal)

Drug: Bledilait Biofer®

2

ACTIVE COMPARATOR

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

Drug: Milk supplemented with ferrous sulphate

Interventions

Bledilait Biofer®DRUG

Bledilait Biofer® 2 mg/100 kcal

1
Milk supplemented with ferrous sulphateDRUG

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

2
Blédilait Biofer®DRUG

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

3

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alain BOCQUET

Besançon, 25000, France

Location

Related Publications (1)

  • 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.

    PMID: 37463435DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jacques LANGUE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 7, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

November 17, 2008

Record last verified: 2008-11

Locations

FR(1)