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Interventional impact of liposomal iron on iron-deficient children developmental outcome: randomized, double-blind,
Wael A Bahbah1, Zein A Omar1, Ali M El-Shafie1
1Department of Pediatrics, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.
Insights
Early iron supplementation in children with non-anemic iron deficiency (NAID) using liposomal iron (LI) significantly improves development and growth. Treating iron deficiency before anemia onset yields the best outcomes for pediatric development.
Area of Science:
- Pediatric Nutrition
- Developmental Pediatrics
- Clinical Nutrition
Background:
- Iron deficiency (ID) in young children negatively impacts development and growth.
- The reversibility of these effects with iron supplementation is debated.
- A novel liposomal iron (LI) preparation was investigated for its efficacy.
Purpose of the Study:
- To evaluate the effect of liposomal iron (LI) on the development and growth of iron-deficient children.
- To compare LI's impact in non-anemic iron deficiency (NAID) versus iron deficiency anemia (IDA).
- To assess the benefits of early iron intervention before anemia onset.
Main Methods:
- A double-blind, placebo-controlled clinical trial involving 433 children aged 6-59 months.
- Participants screened for iron deficiency anemia (IDA) and non-anemic iron deficiency (NAID).
- NAID and IDA groups received either LI or placebo for four months, with subsequent reevaluation of efficacy, development, and growth.
Main Results:
- The NAID group receiving LI showed significant developmental score improvements (+29.57) compared to placebo (+0.96) (P<0.001).
- The final developmental score in the NAID LI group (181.5) was superior to the IDA group (175.0) (P<0.001).
- Children with NAID receiving placebo showed further deterioration in development and growth.
Conclusions:
- Liposomal iron (LI) is effective and well-tolerated for treating iron deficiency in children.
- Early management of iron deficiency during the NAID stage, prior to anemia, yields optimal growth and developmental outcomes.
- The Ages and Stages Questionnaires is a reliable tool for assessing development in young children.
Background:
Iron deficiency (ID) in children, especially those under five years, has a well-recognized negative impact on development and growth. However, the potential for reversibility with iron supplementation remains debatable. Therefore, we aimed in this double-blind placebo-controlled clinical trial to investigate the effect of the novel iron preparation, Liposomal Iron (LI), on the development and growth of iron-deficient children.
Methods:
For iron deficiency anemia (IDA) and non-anemic iron deficiency (NAID), 433 children aged 6 to 59 months underwent screening. The NAID group was divided into two groups: one group received a placebo, while the interventional group received liposomal iron for four months, as in the IDA group. Then, compared to baseline, efficacy, development, and growth were reevaluated.
Results:
The NAID interventional group showed significant improvement in developmental total scores compared to the NAID placebo group with a mean difference of +29.57 versus +0.96 (P < 0.001). Furthermore, the final score was notably superior in the NAID interventional group 181.5, compared to the IDA group, 175.0 (P < 0.001).
Conclusions:
Liposomal iron showed, in addition to good efficacy and tolerability, a favorable impact on the development and growth of iron-deficient children. However, the best results were obtained from early management prior to the onset of anemia (NAID).
Impact:
NAID, though common, is still underappreciated, and evidence about the benefits of giving iron to children before IDA progression is limited. The Ages and Stages Questionnaires is a reliable screening tool for development during the critical first five years of life. Through an interventional clinical trial, LI demonstrated an effective and tolerable alternative for ID treatment, while overcoming the usual adverse effects of conventional iron therapies. Growth and developmental outcomes improved significantly with early detection and treatment of ID with LI during the NAID stage than when the supplement was used after anemia emergence. Conversely, children with NAID who received a placebo showed further deterioration.
