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

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 |

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

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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 |
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

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
Contact: David McKenna, MD | 937-208-5696 | dsmckenna@premierhealth.com | |
Contact: Kaye Snow | 937-208-2411 | eksnow@premierhealth.org |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anemia Pregnancy Iron Vitamin C |
Anemia Hematologic Diseases Ascorbic Acid Vitamins Micronutrients Nutrients |
Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |