Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia

NCT06366698 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 23-55
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded.

Conditions

Iron Deficiency Anemia of Pregnancy

Keywords

Anemia; Iron deficiency; Pregnancy; Intravenous iron

Outcome Measures

Primary Outcomes (5)

• Hemoglobin difference

  Change in hemoglobin level after intervention, larger difference mean more improvement in Hgb

  Hemoglobin level obtained prior to treatment and then 4 weeks later

• Ferritin difference

  Change in ferritin level after intervention, larger difference mean more improvement in ferritin level

  Ferritin level obtained prior to treatment and then 4 weeks later

• Delivery Hemoglobin

  Comparing pre-delivery hemoglobin levels

  Obtained at time of delivery

• Rates of blood transfusion

  Comparing rates of blood transfusion at time of delivery between the 2 groups. The number of units transfused will be collected and compared among the groups

  At time of delivery until 6 weeks postpartum

• Symptoms

  Comparing number of anemia symptoms before and after treatment. There are 11 anemia symptoms on the questionnaire. Using a Likert scale from 0 (no symptoms) to 5 (severe symptoms) patient mark each one. The score is totaled up and can range from 0-55.

  4 weeks

Secondary Outcomes (3)

• Preterm delivery

  At the time of delivery

• Depression

  Duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum

• Birthweight

  At time of delivery

Study Arms (2)

Intravenous iron

ACTIVE COMPARATOR

Venofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit.

Drug: Venofer 200 MG Per 10 ML Injection

Oral iron

PLACEBO COMPARATOR

Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery.

Drug: Ferrous sulfate

Interventions

Venofer 200 MG Per 10 ML Injection DRUG

200 mg IV every 2 days until the targeted dose

Also known as: Iron sucrose

Intravenous iron

Ferrous sulfate DRUG

Take 1 tablet every other day with lemon/orange juice

Oral iron

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years of age
• Ferritin level \< 30 ng/mL
• Singe gestation
• Gestational age up to 36 weeks as iron therapy after this has shown to be not beneficial at time of delivery. We will still plan to treat patients \> 36 weeks but not include them in the final analysis
• Plan to delivery at Arrowhead Regional Medical Center (ARMC)

You may not qualify if:

• Maternal age \< 18 years of age
• Incarcerated patients
• Multifetal gestation
• Acute liver/kidney disease
• Active infections
• Known hematological malignancy
• Other causes of anemia such as alpha/beta thalassemia, sickle cell disease, Folate/B12 deficiency, and anemia of chronic diseases
• Known hypersensitivity with IV iron
• Severe symptoms of anemia requiring blood transfusion

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

RECRUITING

Related Publications (12)

• Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646.

  PMID: 26817624 BACKGROUND

• Anemia in Pregnancy: ACOG Practice Bulletin, Number 233. Obstet Gynecol. 2021 Aug 1;138(2):e55-e64. doi: 10.1097/AOG.0000000000004477.

  PMID: 34293770 BACKGROUND

• Achebe MM, Gafter-Gvili A. How I treat anemia in pregnancy: iron, cobalamin, and folate. Blood. 2017 Feb 23;129(8):940-949. doi: 10.1182/blood-2016-08-672246. Epub 2016 Dec 29.

  PMID: 28034892 BACKGROUND

• Tigga MP, Debbarma AP. A comparative study to evaluate oral iron and intravenous iron sucrose for treatment of anemia in pregnancy in a poor socioeconomic region of Northeast India. Tzu Chi Med J. 2019 Jul 24;32(3):258-261. doi: 10.4103/tcmj.tcmj_99_19. eCollection 2020 Jul-Sep.

  PMID: 32955516 BACKGROUND

• Chua S, Gupta S, Curnow J, Gidaszewski B, Khajehei M, Diplock H. Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial. BMC Pregnancy Childbirth. 2017 Dec 19;17(1):424. doi: 10.1186/s12884-017-1596-x.

  PMID: 29258541 BACKGROUND

• Ng O, Keeler BD, Mishra A, Simpson JA, Neal K, Al-Hassi HO, Brookes MJ, Acheson AG. Iron therapy for preoperative anaemia. Cochrane Database Syst Rev. 2019 Dec 7;12(12):CD011588. doi: 10.1002/14651858.CD011588.pub3.

  PMID: 31811820 RESULT

• Nicholls G, Mehta R, McVeagh K, Egan M. The Effects of Intravenous Iron Infusion on Preoperative Hemoglobin Concentration in Iron Deficiency Anemia: Retrospective Observational Study. Interact J Med Res. 2022 Feb 3;11(1):e31082. doi: 10.2196/31082.

  PMID: 35113024 RESULT

• Lewkowitz AK, Stout MJ, Cooke E, Deoni SC, D'Sa V, Rouse DJ, Carter EB, Tuuli MG. Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial. Am J Perinatol. 2022 Jun;39(8):808-815. doi: 10.1055/s-0041-1740003. Epub 2021 Nov 28.

  PMID: 34839481 RESULT

• Wong L, Smith S, Gilstrop M, Derman R, Auerbach S, London N, Lenowitz S, Bahrain H, McClintock J, Auerbach M. Safety and efficacy of rapid (1,000 mg in 1 hr) intravenous iron dextran for treatment of maternal iron deficient anemia of pregnancy. Am J Hematol. 2016 Jun;91(6):590-3. doi: 10.1002/ajh.24361. Epub 2016 Apr 13.

  PMID: 26971581 RESULT

• Hansen R, Sommer VM, Pinborg A, Krebs L, Thomsen LL, Moos T, Holm C. Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Arch Gynecol Obstet. 2023 Oct;308(4):1165-1173. doi: 10.1007/s00404-022-06768-x. Epub 2022 Sep 15.

  PMID: 36107229 RESULT

• Govindappagari S, Burwick RM. Treatment of Iron Deficiency Anemia in Pregnancy with Intravenous versus Oral Iron: Systematic Review and Meta-Analysis. Am J Perinatol. 2019 Mar;36(4):366-376. doi: 10.1055/s-0038-1668555. Epub 2018 Aug 19.

  PMID: 30121943 RESULT

• Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.

  PMID: 31413088 RESULT

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Interventions

Ferric Oxide, Saccharated; Injections; ferrous sulfate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are initially randomized to either PO or IV iron, after the initial 4-week treatment patients in the PO iron group can switch to IV iron if labs continue to show persist iron deficiency anemia.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: November 21, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)