Hypoferritinemia Without Anemia Among Reproductive Age Females

NCT06437080 | Active Not Recruiting DMC

• 1 other identifier: 70122031
• Study Type: interventional
• Target: 1,331
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this randomized controlled trial is to compare the treatment outcomes of oral iron supplementation (Group A) versus Intravenous (IV) iron supplementation (Group B) versus normal diet (no treatment) (Group C) on the serum ferritin level and to determine the outcomes in the severity of symptoms of HWA, among reproductive age females (age 18-45) with hypoferritinemia without Anemia (HWA), after four months of the start of the intervention. The main questions it aims to answer are:

• Randomly divided into 3 groups (A, B and C) to receive treatment.
• 100 patients will be allocated to each of the three study groups i.e., group A, B and C. The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will remain on their normal diet,
• Visit the clinic once every 1 month for 03 months for doses and assessment of symptoms and adverse events will be done.
• All 03 groups will be called after one month of the last dose and the blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and the severity of symptoms to assess the effectiveness of the intervention.

Conditions

Hypoferritenemia Without Anemia (HWA); Iron Deficiency Without Anemia)

Keywords

Hypoferritenemia without Anemia (HWA); Reproductive age females; Symptoms of HWA; Determinants of HWA; Low serum ferritin levels, Iron deficiency; Cross-sectional study (Phase 1); Randomized controlled trial (Phase 2); Transferrin saturation (TSAT); Intervention

Outcome Measures

Primary Outcomes (8)

• Symptom severity scale

  Symptom severity score before intervention: This questionnaire contains eight questions with multiple-choice responses, with a score ranging from 0 point (not at all), 1 point (mild symptoms/ rarely), 2 points (moderate/ sometimes) and 3 points (severe/ frequently). The total symptom severity score will be calculated as the mean of the scores for the eight individual items and will be recorded at week 1

  Week 1 (Baseline)

• Determinants of Serum Ferritin value

  A questionnaire will be use to access the determinants. The questions included are blood donation history, vitamin supplementation drug, medication history, total preganacies, currently pregnant or lactating, heavy menstural bleeding, number of days of menstural bleeding and pads changed, frequency of stools per day, family history of anemia, frequency of meals per day and meal skipping

  Week 1 (Baseline)

• Socio demographic characteristics of participants

  The characteristics that will be surveyed at level of education, region, religion, income, marital status, number of children, antenatal care and working status

  Week 1 (Baseline)

• Dietary Diversity questionnaire

  For pattern of diet intake: History regarding daily meal frequency and skipping meals and 24 hour recall dietary of an individual will be surveyed: The score of all food groups will then be computed to get the final DDS. DDS of ≤3 will be considered low, 4-5 will be considered as moderate and ≥6 will be considered as a high DDS.

  Week 1 (Baseline)

• Serum ferritin levels

  Serum ferritin levels before intervention

  Week 1 (Baseline)

• Hemoglobin levels

  Complete blood count (CBC)

  week 1 (Baseline)

• Thyroid-stimulating hormone (TSH)

  Thyroid functions

  Week 2

• Random blood sugar

  blood sugar levels

  Week 2

Secondary Outcomes (5)

• Adverse events

  Week 6, 10, 16

• Symptom severity scale

  Week 6, 10, 16

• Change in serum ferritin levels as result of oral intervention: Fersip

  Week 16

• Change in serum ferritin levels as result of intravenous (IV) iron intervention: Ferinject

  Week 16

• Comparison of treatment outcomes of groups (A, B and C)

  Week 16

Study Arms (3)

Oral iron supplement

ACTIVE COMPARATOR

100 participants of Group A will get oral iron supplementation (Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron), 100 mg for 03 months. Participants will consume 01 tablet per day for 03 months. After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.

Drug: Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg

Intravenous (IV) iron supplementation

ACTIVE COMPARATOR

100 participants of Group B will get IV iron supplementation (Ferric Carboxymaltose) for 03 months (01 dose per month for 03 months). After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.

Drug: Ferric Carboxymaltose

Normal diet

NO INTERVENTION

100 participants will remain on their normal diet for 03 months. After 03 months blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.

Interventions

Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg DRUG

01 tablet daily for 03 months, This is assigned to Group A.

Also known as: Fersip

Oral iron supplement

Ferric Carboxymaltose DRUG

03 doses (50 mg iron/mL) per month for 03 months. This is assigned to Group B.

Also known as: Ferinject

Intravenous (IV) iron supplementation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Reproductive age females: 18 to 45 years
• Clinical symptoms of iron deficiency which are fatigue/ tiredness, poor work productivity, poor attention and memory loss, sore tongue, poor condition of skin, nails or hair, including hair loss, delayed skin wound healing, palpitation and restless leg syndrome
• Normal CBC: hemoglobin level12mg/dl and above
• Serum ferritin levels: below 30 ng/ml
• Normal thyroid levels
• Normal blood sugar levels
• Willing and able to sign informed consent

You may not qualify if:

• Males
• Post-menopausal
• Premature menopause
• Anemic Females: hemoglobin levels i.e. less than 12 g/dl
• Serum ferritin level above 30 ng/ml.
• Disturbed thyroid levels
• Disturbed blood sugar levels
• Pregnant
• Lactating
• Blood donors
• Co-morbidities i.e., celiac disease, hemorrhoids, malignancies, hematuria, ulcers, heart failure, renal failure, chronic gastric symptoms/ gastric ulcers, chronic liver disease, disturbed thyroid levels and diabetes
• Any medication or supplement which may impact iron metabolism.
• History of iron or multivitamins supplementation in the last 3 months

Sponsors & Collaborators

• Akram Medical Complex: lead
• Scotmann Pharmaceuticals: collaborator
• The Searle Company Limited Pakistan: collaborator

Study Sites (4)

Fatima Memorial Hospital

Lahore, Punjab Province, 54782, Pakistan

Location

General Hospital Lahore

Lahore, Punjab Province, 54782, Pakistan

Location

Gulab Devi Hospital

Lahore, Punjab Province, 54782, Pakistan

Location

Sir Gangaram Hospital

Lahore, Punjab Province, 54782, Pakistan

Location

Related Publications (3)

• Abuaisha M, Itani H, El Masri R, Antoun J. Prevalence of Iron Deficiency (ID) without anemia in the general population presenting to primary care clinics: a cross-sectional study. Postgrad Med. 2020 Apr;132(3):282-287. doi: 10.1080/00325481.2020.1715701. Epub 2020 Jan 22.

  PMID: 31933400 BACKGROUND

• Adams J, White M. Characterisation of UK diets according to degree of food processing and associations with socio-demographics and obesity: cross-sectional analysis of UK National Diet and Nutrition Survey (2008-12). Int J Behav Nutr Phys Act. 2015 Dec 18;12:160. doi: 10.1186/s12966-015-0317-y.

  PMID: 26684833 BACKGROUND

• Al-Jafar HA. HWA: Hypoferritinemia without anemia a hidden hematology disorder. J Family Med Prim Care. 2017 Jan-Mar;6(1):69-72. doi: 10.4103/2249-4863.214986.

  PMID: 29026752 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr. Abdul Majeed Akhtar, MBBS, PhD

  The univeristy of Lahore

  STUDY CHAIR

• Dr. Rubeena Zakir, MBBS, PhD

  University of Punjab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: After randomization, 100 patients will be allocated to each of the three study groups, (total participants selected 300) i.e., group A, B and C. The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will remain on their normal diet All 03 groups will be called and their blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 31, 2024
• Study Start: October 10, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (4)