Once Versus Twice Daily Iron Supplementation in Pregnant Women

NCT02839096 | Terminated Results

• 1 other identifier: 2004638
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation

Conditions

Anemia in Pregnancy

Outcome Measures

Primary Outcomes (2)

• Hemoglobin

  Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one. Postpartum day 1 hemoglobin was estimated from hematocrit by dividing by 2.941.

  Change in hemoglobin from baseline to one day postpartum

• Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire

  Record the incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionnaire.

  From enrollment to delivery, which will be an average of 10-12 weeks

Secondary Outcomes (1)

• Incidence of Blood Transfusion at Delivery

  At delivery

Study Arms (2)

Once Daily Dosing

OTHER

Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening

Drug: Placebo; Drug: Ferrous Sulfate

Twice Daily Dosing

OTHER

Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening

Drug: Ferrous Sulfate

Interventions

Placebo DRUG

Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate

Also known as: Iron

Once Daily Dosing

Ferrous Sulfate DRUG

Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.

Also known as: Iron

Once Daily Dosing; Twice Daily Dosing

Eligibility Criteria

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

You may qualify if:

• Singleton gestation
• Iron deficiency anemia as defined by a Hgb of less than 11mg/dL in the first and 3rd trimester and 10.5mg/dL in the 2nd trimester and a serum ferritin of less than 15ug/mL.
• In accordance with American College of Obstetricians and Gynecologists (ACOG) guidelines, the Hgb cutoff will be reduced by 0.8mg/dL in African American women.
• In accordance with the standard of care, African American women and those with a mean corpuscular volume (MCV) on their routine screening complete blood count (CBC) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment.

You may not qualify if:

• Multiple gestation
• Maternal hemoglobinopathy or hemochromatosis,
• Irritable bowel disease or irritable bowel syndrome
• History of bariatric surgery or extensive bowel surgery
• Individuals already receiving iron supplementation aside from prenatal vitamins.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Interventions

Iron; ferrous sulfate

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Limitations and Caveats

A sample size calculation predicted that 17 participants would be needed in each treatment arm. However, accrual was halted prematurely due to the move of the principal investigator to another institution. In total, 20 subjects were randomized in the study. The gastrointestinal symptom questionnaire was not completed by one subject and delivery data were not available for a separate subject, who did not deliver at the University of Missouri.

Results Point of Contact

• Title: Research Success Core
• Organization: University of Missouri School of Medicine

obgynresearchsuccesscore@health.missouri.edu

(573) 817-3386

Study Officials

• Mistie P Mills, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Clinical Research Unit provides randomization order to the Investigational Pharmacy, which provides treatment or placebo tablets sets to the care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Ob/Gyn & Women's Health

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: July 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available May 01, 2021 and will be available for 10 years from that date.
• Access Criteria: 1. a commitment to using the data only for research purposes and not seek to identify any individual participant 2. restrictions on redistribution of the data to third parties 3. a commitment to securing the data using appropriate computer technology 4. a commitment to destroying or returning the data after analyses are completed 5. completion of a data-sharing agreement between the researcher requesting data and the University of Missouri

Locations

US (1)