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Effect of Ascorbic Acid Supplementation in Pregnancy on Anemia (AAA) (AAA)

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ClinicalTrials.gov Identifier: NCT03564756
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Wright State University
Five Rivers Health Centers
Information provided by (Responsible Party):
David S. McKenna, Fetal Medicine Foundation

Study Description
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Brief Summary:
A. Anemia is a common problem affecting pregnancy and can result in profound consequences to both the mother and the growing fetus. Current treatment usually includes administration of oral or IV iron, or blood transfusions. Vitamin C is known to affect iron metabolism and has been shown to improve outcomes when used in addition to iron, however, few studies have been performed in pregnancy. The primary aim of this study is to identify the effects of vitamin C on anemia in pregnancy. The Investigators propose a double-blind, randomized placebo controlled trial of 1000mg vitamin C supplementation in 200 low risk pregnancies with iron-deficiency anemia. All newly enrolled patients, who meet inclusion and exclusion criteria, will receive the standard of care evaluation and treatment for anemia in pregnancy. Additionally, patients will be randomized to receive either placebo or vitamin C and compliance monitored with a pill diary. Data will be analyzed by T tests and Mann-Whitney U test. If the data shows a positive statistical significance, vitamin C may be a useful supplement to iron in treating anemia.

Condition or disease Intervention/treatment Phase
Anemia in Pregnancy Dietary Supplement: Vitamin C Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Parallel Group, Placebo Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Effect of Ascorbic Acid Supplementation in Pregnancy on Anemia (AAA)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Vitamin C

Arms and Interventions
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Arm Intervention/treatment
Experimental: Iron + Vitamin C
One iron tablet once a day plus a 500 mg vitamin C tablet twice a day until delivery.
 Dietary Supplement: Vitamin C
1000mg Vitamin C per day
Other Name: Ascorbic Acid
No Intervention: Iron + Placebo
One iron tablet once a day plus a placebo tablet twice a day until delivery.


Outcome Measures
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Primary Outcome Measures :
  1. Change in serum hemoglobin [ Time Frame: To be measured at 1st prenatal visit, 28 weeks', and at delivery ]
    Change in serum hemoglobin


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational age at enrollment less than 20 0/7 weeks,
  • singleton gestation,
  • iron deficiency anemia defined as maternal serum ferritin levels less than 15 micrograms/dL, and
  • planned delivery at Miami Valley Hospital.

Exclusion Criteria:

  • vitamin C use >150mg/day (typical prenatal vitamin contains 60mg Vitamin C),
  • diabetes (gestational, types 1,2); chronic medical disease;
  • known or discovered hemoglobinopathy (including heterozygous states);
  • known metabolic disease that may contribute to impaired iron absorption (including a history of bariatric surgery, renal disease and an inability to tolerate oral iron);
  • known fetal abnormalities;
  • participation in another interventional trial;
  • illicit drug or alcohol use
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564756


Contacts
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Contact: David McKenna, MD 937-208-5696 dsmckenna@premierhealth.com
Contact: Kaye Snow 937-208-2411 eksnow@premierhealth.org

Locations
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United States, Ohio
Five Rivers Health Centers Recruiting
Dayton, Ohio, United States, 45409
Contact: David McKenna, MD    937-208-5696    dsmckenna@premierhealth.com   
Contact: Kaye Snow    937-208-2411    eksnow@premierhealth.com   
Principal Investigator: David McKenna, MD         
Sub-Investigator: Zoe Gauthier, DO         
Sub-Investigator: Keshia Torres-Shafer, MD         
Sponsors and Collaborators
Fetal Medicine Foundation
Wright State University
Five Rivers Health Centers
More Information
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Publications:

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Responsible Party: David S. McKenna, Principal Investigator, Fetal Medicine Foundation
ClinicalTrials.gov Identifier: NCT03564756    
Other Study ID Numbers: AAA-001
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be used by the study team to test the study hypothesis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David S. McKenna, Fetal Medicine Foundation:
Anemia
Pregnancy
Iron
Vitamin C
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Ascorbic Acid
Vitamins
Micronutrients
Nutrients
 Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents