Study of Oral Sucrosomial Iron Supplementation Plus Gluten-Free Diet in Children 8-18 Years With Celiac Disease and Iron Deficiency or Anemia

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.

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