Actively Recruiting

Phase Not Applicable
Age: 8Years - 18Years
All Genders
ID07563582

Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial

Led by Istituto Giannina Gaslini · Updated on 2026-05-04

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

I

Istituto Giannina Gaslini

Lead Sponsor

P

Pharmanutra S.p.a.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying children and adolescents with newly diagnosed celiac disease who also have iron deficiency or anemia caused by poor iron absorption and chronic inflammation. The goal is to see if adding Sucrosomial iron supplements to a gluten-free diet helps restore iron levels and hemoglobin faster than following the diet alone. This randomized, double-blind, placebo-controlled study focuses on school-age children with low iron stores or iron deficiency anemia. Participants will receive either oral Sucrosomial iron drops or placebo drops along with their gluten-free diet for 6 months. Dosage varies by age and development stage, with different amounts given to those with hypoferritinemia compared to those with anemia. The study includes two groups: one with low iron stores and one with anemia, each randomized to active or placebo treatment. During the 6-month treatment, researchers will measure the time it takes for iron levels to normalize, changes in hemoglobin, iron markers, vitamin B12, folate, and fatigue scores. They will also assess quality of life, adherence to the gluten-free diet, gastrointestinal symptoms, and monitor for any treatment-related side effects. Total participation lasts about 6 months from enrollment to the end of treatment.

CONDITIONS

Brief Title

Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of celiac disease according to current European ESPGHAN guidelines with confirmed low iron stores or iron deficiency anemia
  • Age between 8 and 18 years at diagnosis
  • No oral iron supplements in the 30 days before diagnosis and no intravenous iron in the 90 days before diagnosis
  • Have not started a gluten-free diet before diagnosis
  • Other causes of anemia have been excluded
  • Able and willing to participate with informed consent from parents or guardians
Not Eligible

You will not qualify if you...

  • Potential celiac disease without confirmed diagnosis
  • Hemoglobin less than 8 g/dL at screening
  • Other causes of anemia, blood disorders, or clotting problems
  • Active bleeding, surgery, or major trauma in the last 6 months
  • Other inflammatory diseases, cancers, or food allergies mediated by IgE
  • Syndromes or vascular malformations
  • Pregnant or breastfeeding
  • Known allergy or sensitivity to study products or ingredients
  • Use of oral iron in the 30 days or intravenous iron in 90 days before diagnosis
  • Use of other investigational drugs within 30 days before or during the study
  • Any condition the investigator feels makes participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive oral Sucrosomial iron supplementation or placebo drops in addition to a gluten-free diet to treat iron deficiency or anemia.

Regular visits during the 6-month treatment period

Trial Site Locations

Total: 1 location

1

IRCCS Istituto Giannina Gaslini, pad 16

Genova, Italy, Italy, 16143

Actively Recruiting

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Research Team

M

Marco Crocco, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effects of different regimens of iron prophylaxis on maternal iron status and pregnancy outcome: a randomized control trial.

Francesca Parisi, Cristiana Berti, Chiara Mandò...

https://pubmed.ncbi.nlm.nih.gov/27588568

PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations.

J W Varni, M Seid, P S Kurtin

https://pubmed.ncbi.nlm.nih.gov/11468499

CDDUX: a disease-specific health-related quality-of-life questionnaire for children with celiac disease.

Roesja K van Doorn, Lex M F Winkler, Koos H Zwinderman...

https://pubmed.ncbi.nlm.nih.gov/18664865

The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module.

James W Varni, Tasha M Burwinkle, Ernest R Katz...

https://pubmed.ncbi.nlm.nih.gov/11932914

Sucrosomial Iron Supplementation in Anemic Patients with Celiac Disease Not Tolerating Oral Ferrous Sulfate: A Prospective Study.

Luca Elli, Francesca Ferretti, Federica Branchi...

https://pubmed.ncbi.nlm.nih.gov/29522446