Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia

NCT03562143 | Completed

• 1 other identifier: GCO 18-1781
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are serious and can include diminished intellectual and productive capacity and possibly increased susceptibility to infection in mothers and infants, low birthweight, and premature births, hence the importance of appropriate treatment during pregnancy. Most guidelines recommend an increase in iron consumption by about 15-30 mg/day, an amount readily met by most prenatal vitamin formulations. This is adequate supplementation for non-anemic and non-iron-deficient women. However, women with iron deficiency anemia should receive an additional 30-20 mg/day until the anemia is corrected. It is not clear whether intermittent administration of oral iron is equivalent to once daily to rise the hemoglobin levels in pregnant women with iron deficiency anemia. Alternate day treatment with supplemental iron has been suggested as a way to improve its absorption because daily doses may suppress the mucosal uptake of iron even in the presence of iron deficiency until the intestinal mucosa completes its turnover. Another possible factor associated with the frequency of iron dosing is related to hepcidin, the central regulatory molecule in the metabolism of iron in mammals. The synthesis of hepcidin is controlled by 3 kinds of signals: inflammation; the need for increased erythropoiesis, and an iron status signal based on plasma iron levels and iron stores. If plasma iron levels or iron stores are increased, the resulting signal increases hepcidin levels, thereby blocking iron absorption and its release from stores (liver, macrophages) and preventing iron overload.This hepcidin effect, suppressing iron absorption, could last as long as 48h. In this study, the researchers aim to determine if alternate day dosing of iron in pregnant women with iron deficiency anemia results in improved levels of hemoglobin or hematocrit and ferritin. Hepcidin levels will be compared between patients on daily iron supplementation versus alternate day supplementation. The researchers will also evaluate if alternate day dosing of iron supplementation results in a better side effect profile, and with better patient compliance.

Conditions

Iron Deficiency Anemia

Keywords

Iron; Deficiency; Anemia; Supplementation; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin Level

  The change in the level of hemoglobin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.

  baseline and 6 weeks

Secondary Outcomes (3)

• Change in Ferritin Level

  baseline and 6 weeks

• Change in Fasting Hepcidin Level

  Baseline and Day 43 post treatment

• Side effects from Iron Supplementation Questionnaire

  6 weeks

Study Arms (2)

Alternate-day iron supplementation

EXPERIMENTAL

Patients taking iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) for 6 weeks.

Dietary Supplement: Ferrous Sulfate

Daily iron supplementation

ACTIVE COMPARATOR

Patients taking iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) for 6 weeks.

Dietary Supplement: Ferrous Sulfate

Interventions

Ferrous Sulfate DIETARY_SUPPLEMENT

Patients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks.

Also known as: Alternate-day iron supplementation

Alternate-day iron supplementation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients with iron deficiency anemia, defined as Hb less than 11.0 or hematocrit less than 33% with ferritin 25 ug/L
• Age 18-64 years old.
• Gestational age between 12 0/7 weeks and 34 0/7 weeks.
• No other known causes of anemia (Folate or vit b12 deficiency anemia, sideroblastic anemia, thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, anemia of chronic disease). Anemic patients with a low ferritin level and a mean corpuscular volume (MCV) \>95 will have folate and vitamin B12 measured since some patients might have combined causes of anemia and might not respond as expected to iron supplementation only.
• Patients will also be required to have a normal HB electrophoresis; this is a routine test obtained on all prenatal patients.

You may not qualify if:

• Patients currently receiving iron supplementation
• Malabsorptive and restrictive bariatric surgery
• Inflammatory bowel disease
• Irritable bowel syndrome
• Celiac disease/atrophic gastritis/Helicobacter pylori
• Active infection (ferritin can be falsely elevated since apoferritin is an acute-phase protein like CRP and increases both during infections and inflammatory reactions eg postoperatively).
• Patients with contraindications to iron supplementation such as iron overload or hypersensitivity

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

Related Publications (8)

• Sloan NL, Jordan E, Winikoff B. Effects of iron supplementation on maternal hematologic status in pregnancy. Am J Public Health. 2002 Feb;92(2):288-93. doi: 10.2105/ajph.92.2.288.

  PMID: 11818308 BACKGROUND

• Alleyne M, Horne MK, Miller JL. Individualized treatment for iron-deficiency anemia in adults. Am J Med. 2008 Nov;121(11):943-8. doi: 10.1016/j.amjmed.2008.07.012.

  PMID: 18954837 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

• Short MW, Domagalski JE. Iron deficiency anemia: evaluation and management. Am Fam Physician. 2013 Jan 15;87(2):98-104.

  PMID: 23317073 BACKGROUND

• Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.

  PMID: 26289639 BACKGROUND

• Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016 Jan;91(1):31-8. doi: 10.1002/ajh.24201. Epub 2015 Nov 17.

  PMID: 26408108 BACKGROUND

• Allen LH. Anemia and iron deficiency: effects on pregnancy outcome. Am J Clin Nutr. 2000 May;71(5 Suppl):1280S-4S. doi: 10.1093/ajcn/71.5.1280s.

  PMID: 10799402 BACKGROUND

• Breymann C. Iron Deficiency Anemia in Pregnancy. Semin Hematol. 2015 Oct;52(4):339-47. doi: 10.1053/j.seminhematol.2015.07.003. Epub 2015 Jul 10.

  PMID: 26404445 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Melissa T Chu Lam, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients that agree to participate will be randomized to receive either 1 tablet of 325mg ferrous sulfate (65 mg of elemental iron) on consecutive days for 6 weeks or 2 tablets together (130 mg of elemental iron ) every other day for 6 weeks. Both groups will be receiving the same total amount of iron over the study period (2730 mg of elemental iron over 6 weeks).

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: August 31, 2018
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

US (1)