Daily vs Intermittent Iron Therapy in Pregnancy

NCT03706638 | Completed

• 1 other identifier: 18-181-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized non inferiority trial to evaluate the response to iron therapy in the standard daily vs. intermittent (three-four times a week on nonconsecutive days) groups by using hematological markers (hemoglobin, hematocrit, transferrin, hepcidin, ferritin, human soluble transferrin receptor). The secondary outcome is to evaluate gastrointestinal discomfort and adherence to therapy between two treatment groups.

Conditions

Iron Deficiency Anemia of Pregnancy

Keywords

Iron Deficiency Anemia; Pregnancy; Side Effects

Outcome Measures

Primary Outcomes (1)

• Hematologic values assessed for anemia

  Hematologic values of hemoglobin, hematocrit, transferrin, hepcidin, human soluble transferrin receptor and ferritin.

  This will be measured 4-6 weeks after starting treatment.

Secondary Outcomes (1)

• Scores on self report survey of gastrointestinal adverse side effects after oral iron supplementation

  Side effects will be reviewed every 2 weeks for a period of 4-6 weeks.

Study Arms (2)

Daily

OTHER

Patients randomized to this arm will take ferrous sulfate 325 mg every day.

Dietary Supplement: Ferrous Sulfate

Intermittent (Every other day)

OTHER

Patient's randomized to this arm will take ferrous sulfate 325 mg every other day.

Dietary Supplement: Ferrous Sulfate

Interventions

Ferrous Sulfate DIETARY_SUPPLEMENT

Patients would be randomized to either taking ferrous sulfate daily or every other day (on non consecutive days).

Daily; Intermittent (Every other day)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who are not underweight (BMI \< 18.5 kg/m2)
• Reproductive-aged women 18-50
• Singleton Pregnancy.
• Patients undergoing third trimester blood work from 26-28 weeks.
• Women who have had previously normal first-trimester blood work (hemoglobin, hematocrit, MCV) without any evidence of existing anemia.
• Pregnant women with anemia designated with hemoglobin concentration less than 11 g/dL or hematocrit less than 33%
• No pre-existing iron deficiency anemia or not already on iron supplementation.

You may not qualify if:

• Women with medical problems known to affect iron metabolism or homeostasis
• Women with existing thalassemias or anemias.
• Women with abnormal bloodwork indicating anemia earlier in the pregnancy.
• Women are already taking iron supplementation during the pregnancy for treatment of iron deficiency anemia.
• Chronic illness is influencing iron absorption.
• Underlying malabsorption disease.
• History of bariatric surgery.
• Severe anemia with maternal hemoglobin levels less than 6 g/dL
• Preterm Labor, PPROM, signs of infection.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

Related Publications (11)

• Looker AC, Dallman PR, Carroll MD, Gunter EW, Johnson CL. Prevalence of iron deficiency in the United States. JAMA. 1997 Mar 26;277(12):973-6. doi: 10.1001/jama.1997.03540360041028.

  PMID: 9091669 BACKGROUND

• American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 95: anemia in pregnancy. Obstet Gynecol. 2008 Jul;112(1):201-7. doi: 10.1097/AOG.0b013e3181809c0d. Erratum In: Obstet Gynecol. 2020 Jan;135(1):222. doi: 10.1097/AOG.0000000000003624.

  PMID: 18591330 BACKGROUND

• Khalafallah AA, Dennis AE. Iron deficiency anaemia in pregnancy and postpartum: pathophysiology and effect of oral versus intravenous iron therapy. J Pregnancy. 2012;2012:630519. doi: 10.1155/2012/630519. Epub 2012 Jun 26.

  PMID: 22792466 BACKGROUND

• Daru J, Allotey J, Pena-Rosas JP, Khan KS. Serum ferritin thresholds for the diagnosis of iron deficiency in pregnancy: a systematic review. Transfus Med. 2017 Jun;27(3):167-174. doi: 10.1111/tme.12408. Epub 2017 Apr 20.

  PMID: 28425182 BACKGROUND

• van den Broek NR, Letsky EA, White SA, Shenkin A. Iron status in pregnant women: which measurements are valid? Br J Haematol. 1998 Dec;103(3):817-24. doi: 10.1046/j.1365-2141.1998.01035.x.

  PMID: 9858238 BACKGROUND

• Koenig MD, Tussing-Humphreys L, Day J, Cadwell B, Nemeth E. Hepcidin and iron homeostasis during pregnancy. Nutrients. 2014 Aug 4;6(8):3062-83. doi: 10.3390/nu6083062.

  PMID: 25093277 BACKGROUND

• Cook JD, Flowers CH, Skikne BS. The quantitative assessment of body iron. Blood. 2003 May 1;101(9):3359-64. doi: 10.1182/blood-2002-10-3071. Epub 2003 Jan 9.

  PMID: 12521995 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

• F. Gary Cunningham, John C. Hauth, Kenneth J. Leveno, Larry Gilstrap Iii, Steven L. Bloom, & Katharine D. Wenstrom. (2010). Williams obstetrics. Williams Obstetrics (pp. 1081).

  RESULT

• Pena-Rosas JP, De-Regil LM, Dowswell T, Viteri FE. Intermittent oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2012 Jul 11;7(7):CD009997. doi: 10.1002/14651858.CD009997.

  PMID: 22786531 RESULT

• 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 RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treatment groups are blinded and becomes unmasked when assigning the patient to a treatment group. At this time, the patient and the investigator becomes aware of the treatment assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology; Maternal Fetal Medicine Fellowship Program Director

Model Details: Randomized Noninferiority Trial

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: October 25, 2018
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)