Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency

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

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2020-06-22

Brief Summary

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

The study evaluates the efficacy and safety of \>Your\< Iron Syrup, a novel iron-containing dietary supplement, in the management of dietary iron deficiency in children. The study is a randomized, double-blind, placebo-controlled intervention conducted in 16 research centers in Slovenia, collectively enrolling 92 eligible children. Eligibility of children for participation in the study will be determined by screening for hemoglobin and ferritin (combined with C-reactive protein) levels in a sample of capillary blood. Eligible children will receive basic dietary advice on how to increase the consumption of dietary iron and will be invited to participate in the study. Enrolled children will be randomized to either \>Your\< Iron Syrup arm or to placebo arm in a 3:1 ratio, respectively. Changes in body iron stores (ferritin) and in hematological indices as well as occurence of any adverse events will be monitored after 4 and 12 weeks of once-daily supplementation with either \>Your\< Iron Syrup or placebo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Daily Oral Iron Supplementation for Replenishment of Depleted Iron in Adults

NCT05185024

Iron-deficiency Iron Deficiency Anemia

COMPLETED NA

Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA

NCT03523117

Iron Deficiency Anemia

COMPLETED PHASE3

Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India

NCT00213161

Anemia

COMPLETED NA

Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)

NCT04371536

Iron Deficiency Anemia Iron-deficiency

COMPLETED PHASE3

Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.

NCT07324135

Iron Status

NOT_YET_RECRUITING NA

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.

Iron-deficiency

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

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Once daily dose of \>Your\< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Once daily dose of placebo syrup for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Age 9 months to 6 years (inclusive).
* Signed informed consent for screening and for enrollment (parent or legal guardian).
* Iron deficiency with or without mild microcytic anemia not requiring treatment (ferritin ≤20 µg/l and Hb ≥ 100 g/l in a capillary blood sample).

Exclusion Criteria

* Hb \<100 g/l.
* Anemia due to a cause other than iron deficiency.
* Vegan diet.
* Any known concomitant chronic disease (e. g., chronic inflammation, chronic inflammatory bowel disease, malignancy, kidney and/or liver malfunction, lead poisoning).
* Any known allergies to the components of the investigational product.
* Any known medical, physical, or psychological condition that, in the opinion of the investigator, is incompatible with consumption of the investigational product and/or with the conduct of the study.
* Participation in another clinical study less than 1 month before enrollment or current participation in another clinical study.
* Current consumption of iron-containing medicines or dietary supplements.

Minimum Eligible Age

9 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No