NCT03564756

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2.7 years

First QC Date

May 25, 2018

Last Update Submit

September 21, 2022

Conditions

Anemia in Pregnancy

Keywords

AnemiaPregnancyIronVitamin C

Outcome Measures

Primary Outcomes (1)

  • Change in serum hemoglobin

    Change in serum hemoglobin

    To be measured at 1st prenatal visit, 28 weeks', and at delivery

Study Arms (2)

Iron + Vitamin C

EXPERIMENTAL

One iron tablet once a day plus a 500 mg vitamin C tablet twice a day until delivery.

Dietary Supplement: Vitamin C

Iron + Placebo

NO INTERVENTION

One iron tablet once a day plus a placebo tablet twice a day until delivery.

Interventions

Vitamin CDIETARY_SUPPLEMENT

1000mg Vitamin C per day

Also known as: Ascorbic Acid
Iron + Vitamin C

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Five Rivers Health Centers

Dayton, Ohio, 45409, United States

Location

Related Publications (10)

  • 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: 18591330BACKGROUND

  • McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23.

    PMID: 18498676BACKGROUND

  • Abdel Moety GAF, Ali AM, Fouad R, Ramadan W, Belal DS, Haggag HM. Amino acid chelated iron versus an iron salt in the treatment of iron deficiency anemia with pregnancy: A randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:242-246. doi: 10.1016/j.ejogrb.2017.01.003. Epub 2017 Jan 3.

    PMID: 28073037BACKGROUND

  • Hanieh S, Ha TT, Simpson JA, Braat S, Thuy TT, Tran TD, King J, Tuan T, Fisher J, Biggs BA. Effect of low-dose versus higher-dose antenatal iron supplementation on child health outcomes at 36 months of age in Viet Nam: longitudinal follow-up of a cluster randomised controlled trial. BMJ Glob Health. 2017 Sep 22;2(3):e000368. doi: 10.1136/bmjgh-2017-000368. eCollection 2017.

    PMID: 29018582BACKGROUND

  • Joseph B, Ramesh N. Weekly dose of Iron-Folate Supplementation with Vitamin-C in the workplace can prevent anaemia in women employees. Pak J Med Sci. 2013 Jan;29(1):47-52. doi: 10.12669/pjms.291.3016.

    PMID: 24353506BACKGROUND

  • Lane DJ, Richardson DR. The active role of vitamin C in mammalian iron metabolism: much more than just enhanced iron absorption! Free Radic Biol Med. 2014 Oct;75:69-83. doi: 10.1016/j.freeradbiomed.2014.07.007. Epub 2014 Jul 15.

    PMID: 25048971BACKGROUND

  • Rumbold A, Crowther CA. Vitamin C supplementation in pregnancy. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004072. doi: 10.1002/14651858.CD004072.pub2.

    PMID: 15846696BACKGROUND

  • Pena-Rosas JP, De-Regil LM, Gomez Malave H, Flores-Urrutia MC, Dowswell T. Intermittent oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2015 Oct 19;2015(10):CD009997. doi: 10.1002/14651858.CD009997.pub2.

    PMID: 26482110BACKGROUND

  • Sedighi O, Makhlough A, Janbabai G, Neemi M. Comparative study of intravenous iron versus intravenous ascorbic Acid for treatment of functional iron deficiency in patients under hemodialysis: a randomized clinical trial. Nephrourol Mon. 2013 Sep;5(4):913-7. doi: 10.5812/numonthly.12038. Epub 2013 Jul 24.

    PMID: 24350091BACKGROUND

  • Sultana T, DeVita MV, Michelis MF. Oral vitamin C supplementation reduces erythropoietin requirement in hemodialysis patients with functional iron deficiency. Int Urol Nephrol. 2016 Sep;48(9):1519-24. doi: 10.1007/s11255-016-1309-9. Epub 2016 May 11.

    PMID: 27170339BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Parallel Group, Placebo Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 21, 2018

Study Start

August 1, 2019

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Data will be used by the study team to test the study hypothesis

Locations

US(1)