Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy

NCT04594070 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20-0068
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.

Conditions

Pregnancy Related; Iron Deficiency Anemia of Pregnancy

Keywords

Pregnancy; Iron deficiency; Anemia; Iron supplementation

Outcome Measures

Primary Outcomes (2)

• Difference in Hemoglobin Levels From Enrollment to End of Study

  Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy

  Baseline and again 8-9 months later (third trimester of pregnancy)

• Change in Hematocrit in the Third Trimester After Treatment

  Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy

  Baseline and again 8-9 months later (third trimester of pregnancy)

Secondary Outcomes (14)

• Gastrointestinal Side Effects After 2-4 Weeks of Treatment

  2-4 weeks after enrollment

• Complete Blood Count in the Third Trimester

  8-9 months after enrollment (third trimester of pregnancy)

• Serum Ferritin at Time of Enrollment

  Baseline only at time of enrollment

• Total Iron Binding Capacity at Time of Enrollment

  Baseline only at time of enrollment

• Transferrin at Time of Enrollment

  Baseline only at time of enrollment

Study Arms (2)

Daily iron supplementation

ACTIVE COMPARATOR

Oral ferrous sulfate, 325 mg, take once daily

Drug: Ferrous sulfate

Alternate day iron supplementation

EXPERIMENTAL

Oral ferrous sulfated, 650mg, taken once daily every other day

Drug: Ferrous sulfate

Interventions

Ferrous sulfate DRUG

Iron supplementation

Alternate day iron supplementation; Daily iron supplementation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester
• Microcytic anemia
• Singleton gestation in the first or second trimester

You may not qualify if:

• Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery
• Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.)
• History of cardiopulmonary disease
• Severe anemia requiring parental infusion or transfusion of blood products

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Melody Safarzadeh
• Organization: University of Texas Medical Branch Galveston

mesafarz@utmb.edu

9082854962

Study Officials

• Melody Safarzadeh, MD, MS

  UTMB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 20, 2020
• Study Start: October 27, 2020
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)