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Iron Deficiency Anemia TreatmentPhase 4NCT06631612

Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia

A Phase 4 study testing ferric hydroxide polymaltose complex and Albendazole. in people with Iron Deficiency Anemia Treatment, run by Ain Shams University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The goal of this clinical trial is to learn if giving iron supplementation every other day is as effective as giving it daily in children with Iron Deficiency Anemia. The main questions it aims to answer are: 1. Will alternate day regimen improve hemoglobin and iron profile just as well as daily dose? 2. Read more about this study

Who is it for?
Ages 2 to 12 years
Conditions the study is for
Iron Deficiency Anemia Treatment
What is being tested?
ferric hydroxide polymaltose complex and Albendazole.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteEgypt
Study dates
1 Jan 2024to Mar 2025
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children 2-12 years of age diagnosed wit Iron Deficiency anemia according to WHO criteria (hemoglobin below 11 g/dl and transferrin saturation below 16%)

Who cannot join

  • Children already being treated for iron deficiency anemia
  • Children known to have hemolytic anemias
  • Children with GIT disorders that prevent iron absorption (Inflammatory bowel disease,celiac disease …etc)
  • Children with chronic diseases (heart disease,liver disease,kidney disease, endocrinological disease).
  • Children who are underweight or morbidly obese

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams University Hospitals

    Cairo, Abaseya

Other trials in Egypt

About this study

Official title: Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia: a Hospital Based Study

The goal of this clinical trial is to learn if giving iron supplementation every other day is as effective as giving it daily in children with Iron Deficiency Anemia.

The main questions it aims to answer are:

Read more
  1. Will alternate day regimen improve hemoglobin and iron profile just as well as daily dose?
  2. Which group will suffer less side effects from Iron Supplementation?

Participants will be divided into two groups:

Group A: will receive oral Iron supplementation daily for 2 months Group B: will receive oral Iron supplementation every other day for 2 months Participants will be monitored using weekly phone calls to insure compliance and report side effects.

Both groups will be given Albendazole 400 mg once at the beginning of the study to be repeated in 1 week

Read the detailed description

Children will be recruited from the pediatrics general clinic in Al Demerdash Hospital.

After checking fro inclusion and exclusion criteria and signing the informed consent form the following will be carried out.

1-History taking: Caregivers will be asked about:

  1. Sociodemographic data: using a self-structured questionnaire
  • Age of the child
  • Gender of the child
  • Order of birth
  • Consanguinity
  • Mode of delivery (either vaginal delivery or by c-section)
  • Age of the mother and father
  • Level of education or the mother and father
  • Address of the family
  1. Questions about risk factors for iron deficiency anemia/ to exclude other causes of anemia:
  • Prematurity / low birth weight.
  • Duration of exclusive breast feeding
  • Consumption of cow milk before 1 year of age/excessive consumption of cow milk
  • Mother's iron status during pregnancy
  • family history for hemolytic anemias or regular blood transfusions.
  • history of blood transfusions (or hemolysis: pallor ,jaundice, dark urine,anemia)
  • History of chronic illness (Cardiac, hepatic or renal patients).
  • History of chronic blood loss
  1. Questions about symptoms of iron deficiency anemia:

Headache, lack of concentration,fatigue, palpitations, irritability,fainting, wanting to eat odd substances such as dirt or ice (also called pica),,,,etc.

2-Examination:

General examination:

  1. Anthropometric measures (weight,height,BMI).
  2. Look for signs of anemia: Pallor, brittle hair and nails,angular stomatitis,glossitis, Koilonychia or spooning of nails, tachycardia, hyperdynamic circulation.
  3. Abdominal examination: look for tenderness, masses or hepatosplenomegaly. 3-Investigations: (a blood sample of about 5 ml will be drawn twice, once at presentation and again after 8 weeks) Complete Blood Picture (CBC) Iron profile: serum iron, TIBC. Participants will be divided into two groups.

Both groups will receive:

  1. Health education regarding IDA including: Prenatal and postnatal nutrition, the definition of anemia, diagnosis of anemia, factors causing anemia, sources of heme and non-heme iron, foods and nutrients that interfere with and promote iron absorption, and the impact of anemia on toddlers. Also food sources high in nutrients and processing high iron content of complementary breastfeeding.
  2. Treatment for parasitic infections (deworming ) Albendazole 400 mg once.

Then:

Group (1) will receive daily dose of 3 mg/kg ferrous fumarate before bed. Group (2) will receive a dose of 6mg/kg ferrous fumarate before bed every other day with a maximum dose of 180 mg /day.

Participants will be dedicated to the study for 8 weeks. During this time, they will be monitored using weekly phone calls to:

  1. Reinforce the health education message.
  2. make sure they are compliant to their treatment.
  3. monitor if any new symptoms or side effects appear.
  • Outcomes:

Participants will be followed for 8 weeks. Check in after 8 weeks to repeat hemoglobin levels and serum Iron and TIBC.

Being tested
ferric hydroxide polymaltose complex, Albendazole.
Keywords
iron defiiency, Anemia, hepcidin
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ferric hydroxide polymaltose complexDrug

    participants will receive oral iron supplementation according to body weight every other day

  • ferric hydroxide polymaltose complexDrug

    participants will receive oral iron supplementation dose according to body weight daily

  • Albendazole.Drug

    both arms will receive Albendazole 400mg once at the beginning f the study to be repeated after 1 week

Study groups in NCT06631612
Study groupRoleWhat they receive
daily dose of Iron SupplementationActive comparatordaily dose of 3 mg/kg elemental Iron before bed
Receives: Drug: ferric hydroxide polymaltose complex; Drug: Albendazole.
alternate day regimenExperimentalevery other day dose of 3mg/kg elemental Iron before bed
Receives: Drug: ferric hydroxide polymaltose complex; Drug: Albendazole.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in hemoglobin

    treatment will be considered successful if there is an increase of hemoglobin at least 1 g/dl every 4 weeks

    Measured: 8 weeks

  2. change in Iron Profile

    changes in serum Iron will be compared between the two groups

    Measured: 8 weeks

  3. change in iron profile

    change in TIBC will be compared between the two groups

    Measured: 8 weeks

  4. change in iron profile

    change in transferrin saturation will be compared between the two groups

    Measured: 8 weeks

Secondary outcomes (1)
  1. frequency of side effects

    frequency of different side effects (eg: abdominal pain, nausea, vomitting , etc.)will be compared between the two groups

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start1 Jan 2024
  3. Primary completionJan 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631612
Sponsor's protocol ID
FMASU MD288/2023
Status last verified
Oct 2024
First submitted
30 Sep 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all data collected and used in the results will be shared

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