A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects

NCT04778072 | Unknown

• 1 other identifier: AFCRO-80
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intolerance to oral iron. Subjects with intolerance and treatment failure due to oral iron (male and female subjects, aged 18 to 55 years, with mild to moderate iron deficiency, with or without anaemia) are eligible. Sixty subjects are randomised into three groups (14 mg elemental iron, 25mg elemental iron and 50mg elemental iron daily). The primary objective is to assess adherence/persistence (including using pill counts). Secondary objectives are to assess gastrointestinal tolerability, haematological efficacy and health related quality of life.

Conditions

Premenopause; Iron-deficiency; Iron Adverse Reaction; Iron Deficiency Anemia; Heavy Menstrual Bleeding

Keywords

Randomised controlled trial; Double blind; Ferrous sulfate; Intolerance; Oral iron; Adherence; Efficacy; Whey protein; Active Iron

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects adherent/persistent (6 weeks)

  To assess the change in proportion of subjects adherent/persistent (\>80% based on pill counts) from baseline to week 6

  6 weeks

• Proportion of subjects adherent/persistant (12 weeks)

  To assess the change in proportion of subjects adherent/persistant (\>80% based on pill counts) from baseline to week 12

  12 weeks

Secondary Outcomes (7)

• Upper gastrointestinal symptoms (12 weeks)

  12 weeks

• Lower gastrointestinal symptoms (12 weeks)

  12 weeks

• Change in GSRS (12 weeks)

  12 weeks

• Change in haemaglobin (12 weeks)

  12 weeks

• Change in ferritin (12 weeks)

  12 weeks

Other Outcomes (20)

• Median adherence (6 weeks)

  6 weeks

• Median adherence (12 weeks)

  12 weeks

• Change in GSRS (6 weeks)

  6 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

ACTIVE IRON™ (ferrous sulfate) 14 mg elemental iron once daily with matching placebo

Dietary Supplement: Ferrous sulfate 14mg once daily

Group 2

EXPERIMENTAL

ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron once daily with matching placebo

Dietary Supplement: Ferrous sulfate 25mg once daily

Group 3

EXPERIMENTAL

ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron twice daily with matching placebo

Dietary Supplement: Ferrous sulfate 25mg twice daily

Interventions

Ferrous sulfate 14mg once daily DIETARY_SUPPLEMENT

ACTIVE IRON™ (ferrous sulfate) 14 mg elemental iron once daily with matching placebo

Also known as: ACTIVE IRON™

Group 1

Ferrous sulfate 25mg once daily DIETARY_SUPPLEMENT

ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron once daily with matching placebo

Also known as: ACTIVE IRON™

Group 2

Ferrous sulfate 25mg twice daily DIETARY_SUPPLEMENT

ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron twice daily

Also known as: ACTIVE IRON™

Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent
• Be between 18 and 55 years of age
• Have ferritin levels \<30 µg/L
• Have a history of intolerance to oral iron
• Have mild to moderate anaemia (haemoglobin ≥9.5 g/dL and \<12.0 g/dL for females and ≥10.0 g/dL and \<13.0 g/dL for males, up to 30 patients) or no anaemia (up to 30 patients)
• Be in generally good health as determined by the investigator

You may not qualify if:

• A history of dairy allergy or are hypersensitive to any of the components of the test product,
• Are currently taking any iron supplements, or have done so in the previous 2 weeks,
• Current inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• Severe anemia (females with hemoglobin \<9.5 g/dL and males with hemoglobin \<10.0 g/dL)
• Females that have started menopause,
• Females using extended-cycle birth control pills
• Have a significant acute or chronic, unstable and untreated disease or any condition, which contraindicates, in the investigator's judgement, entry to the study,
• Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; for example, no concurrent medication which interferes with the absorption of iron (e.g. tetracyclines, calcium supplements),
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
• Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study,
• Have a malignant disease or any concomitant end-stage organ disease.

Sponsors & Collaborators

• Solvotrin Innovations Ltd: lead

Study Sites (1)

Atlantia Clinical Trials

Cork, Co Cork, T23 R50R, Ireland

Location

Related Publications (8)

• Lopez A, Cacoub P, Macdougall IC, Peyrin-Biroulet L. Iron deficiency anaemia. Lancet. 2016 Feb 27;387(10021):907-16. doi: 10.1016/S0140-6736(15)60865-0. Epub 2015 Aug 24.

  PMID: 26314490 BACKGROUND

• Low MS, Speedy J, Styles CE, De-Regil LM, Pasricha SR. Daily iron supplementation for improving anaemia, iron status and health in menstruating women. Cochrane Database Syst Rev. 2016 Apr 18;4(4):CD009747. doi: 10.1002/14651858.CD009747.pub2.

  PMID: 27087396 BACKGROUND

• McNamee T, Hyland T, Harrington J, Cadogan S, Honari B, Perera K, Fitzgerald AP, Perry IJ, Cahill MR. Haematinic deficiency and macrocytosis in middle-aged and older adults. PLoS One. 2013 Nov 7;8(11):e77743. doi: 10.1371/journal.pone.0077743. eCollection 2013.

  PMID: 24244281 BACKGROUND

• Munoz M, Villar I, Garcia-Erce JA. An update on iron physiology. World J Gastroenterol. 2009 Oct 7;15(37):4617-26. doi: 10.3748/wjg.15.4617.

  PMID: 19787824 BACKGROUND

• Pereira DI, Couto Irving SS, Lomer MC, Powell JJ. A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation. BMC Gastroenterol. 2014 Jun 4;14:103. doi: 10.1186/1471-230X-14-103.

  PMID: 24899360 BACKGROUND

• Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.

  PMID: 29032957 BACKGROUND

• Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.

  PMID: 25700159 BACKGROUND

• Ledwidge M, Ryan F, Seoighe A, Santos-Martinez MJ, Ryan C, Gilmer JGF. Management of iron deficiency in women of childbearing age with oral iron intolerance: a prospective, randomised, controlled trial of three doses of an iron-whey-protein formulation : Prospective RandomisEd study of women of Childbearing age with gastroInteStinal Intolerance to Oral iroN (PRECISION). Int J Clin Pharm. 2024 Apr;46(2):390-400. doi: 10.1007/s11096-023-01640-7. Epub 2023 Dec 26.

  PMID: 38147281 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Menorrhagia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Shauni Fitzgerald, MSC

  Atlantia Clinical Trials

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized into one of three arms (20 subjects per arm) but will be blinded as to which group they are in. The three arms are as follows: Group 1: ACTIVE IRON™ (ferrous sulfate) 14 mg elemental iron once daily (and matching placebo) Group 2: ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron once daily (and matching placebo) Group 3: ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron twice daily (and matching placebo)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three groups in parallel

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: October 8, 2018
• Primary Completion: April 9, 2021
• Study Completion: May 15, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)