Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03564756
Status:
WITHDRAWN
Last Update Posted:
2022-09-22
First Post:
2018-05-25
Brief Title:
Effect of Ascorbic Acid Supplementation in Pregnancy on Anemia AAA
Sponsor:
Fetal Medicine Foundation
Organization:
Fetal Medicine Foundation
Study Overview
Official Title:
Effect of Ascorbic Acid Supplementation in Pregnancy on Anemia AAA
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAA
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
Detailed Description:
A Anemia is the most common hematological abnormality during pregnancy and was found to affect 241 of pregnant women in a WHO study2 The most common types of anemia affecting pregnancy are iron-deficiency and acute blood loss Vitamin C also known as ascorbic acid has been well documented to play an active role in the absorption and metabolism of iron from the gut6 Vitamin C has been used in studies to treat anemic non-pregnant women resulting in significant increases in hemoglobin levels Similar effects have been found in multiple studies using vitamin C as adjunct treatment for hemodialysis patients with non-responsive anemia1012 Vitamin C has already been extensively studied in pregnant women for its effects on preeclampsia preterm birth neonatal morbidity and other outcomes and found to have no adverse effects in doses as high as 1000mg daily or in combination with other medications8 After an extensive literature search very few studies have been performed assessing the effect on hemoglobin levels after vitamin C supplementation One study by Sharma et al supplemented pregnant women with 500mg vitamin C and found a 1804 increase in hemoglobin compared to 549 in the control11 A Cochran Review of 29 studies did not discuss or evaluate the effects of vitamin C on anemia8 Due to the minimal side-effect profile and potential benefits of successfully treating anemia further research in the area is needed
V SPECIFIC AIMS OR OBJECTIVES A To perform a double-blinded randomized placebo controlled trial of 1000mg vitamin c supplementation on iron-deficiency anemia in low-risk pregnancies
VI SIGNIFICANCE TO PATIENT INSTITUTION PROFESSION OR ALL A Anemia has been associated with adverse maternal and fetal outcomes to include but not limited to low birth weight preterm delivery perinatal mortality and postpartum depression1 Per ACOG guidelines all pregnant women should be screened for anemia evaluated for causes and provided supplemental iron A study by Sharma et al has already demonstrated a significant increase in hemoglobin levels in pregnancy with 500mg vitamin C supplementation11 Due to the paucity of research of vitamin C in pregnancy further studies are needed to determine reproducibility
VII METHODS A The investigators plan to enroll 200 patients total 100 per arm Potential subjects will be screened by study personal from the new intakes for prenatal care in the Five Rivers Center for Womens Health A complete blood count CBC is obtained as standard of care at the first prenatal visit The CBC includes hemoglobin level hematocrit and red blood cell indices ie MCV and MCH Pregnant women in the first half of their pregnancy who are found to have a hematocrit level less than 33 Caucasian and other races and less than 31 African American women will be potentially eligible for enrollment Women who are noted to be anemic per these thresholds will have iron studies iron transferrin ferritin and hemoglobin electrophoresis if not already performed as part of the standard of care for the evaluation of anemia during pregnancy1 Inclusion criteria consists of gestational age at enrollment less than 20 07 weeks singleton gestation iron deficiency anemia defined as maternal serum ferritin levels less than 15 microgramsdL and planned delivery at Miami Valley Hospital Exclusion criteria consist of vitamin C use 150mgday typical prenatal vitamin contains 60mg Vitamin C diabetes gestational types 12 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 All risksbenefits will be reviewed and all questions answered prior to the patient being enrolled Written informed consent will be obtained by a study investigator or qualified personnel Gestational dating will be based upon the best obstetrical estimate
B A compounding pharmacy will make 30000 placebo capsules containing an inert substance ie silica based cellulose identical appearing to 30000 capsules of 500mg vitamin C The pharmacy will package 300 pills of either placebo or vitamin C into 200 boxes labeled only with the project name and a number A key containing the known substance of each box and number will be kept by the pharmacy until the end of the study The boxes will be stored in a secured area of the principal investigators office The boxes will be taken to Five Rivers Womens Health Clinic to be distributed to enrolled patients Once enrolled patients will be given a random box and instructed to take 1 pill twice daily Patients will be instructed to record pill usage daily for compliance The patients name and assigned box number will be kept in a locked cabinet At the end of the study the two keys will be compared to determine who received placebo or vitamin C Both groups will receive prescriptions for ferrous sulfate 65mg taken once daily docusate sodium to be taken as needed for constipation and prenatal vitamins once daily Patients will receive follow up labs as part of the standard of care for anemia to include at 28 week and at delivery All data will be collected in an Excel spreadsheet with patient identifiers removed Data will be analyzed by applying basic T tests and the Mann-Whitney-U test to determine the changes in lab values of hemoglobin hematocrit iron transferrin ferritin between experimental and control before and after treatment
V SPECIFIC AIMS OR OBJECTIVES A To perform a double-blinded randomized placebo controlled trial of 1000mg vitamin c supplementation on iron-deficiency anemia in low-risk pregnancies
VI SIGNIFICANCE TO PATIENT INSTITUTION PROFESSION OR ALL A Anemia has been associated with adverse maternal and fetal outcomes to include but not limited to low birth weight preterm delivery perinatal mortality and postpartum depression1 Per ACOG guidelines all pregnant women should be screened for anemia evaluated for causes and provided supplemental iron A study by Sharma et al has already demonstrated a significant increase in hemoglobin levels in pregnancy with 500mg vitamin C supplementation11 Due to the paucity of research of vitamin C in pregnancy further studies are needed to determine reproducibility
VII METHODS A The investigators plan to enroll 200 patients total 100 per arm Potential subjects will be screened by study personal from the new intakes for prenatal care in the Five Rivers Center for Womens Health A complete blood count CBC is obtained as standard of care at the first prenatal visit The CBC includes hemoglobin level hematocrit and red blood cell indices ie MCV and MCH Pregnant women in the first half of their pregnancy who are found to have a hematocrit level less than 33 Caucasian and other races and less than 31 African American women will be potentially eligible for enrollment Women who are noted to be anemic per these thresholds will have iron studies iron transferrin ferritin and hemoglobin electrophoresis if not already performed as part of the standard of care for the evaluation of anemia during pregnancy1 Inclusion criteria consists of gestational age at enrollment less than 20 07 weeks singleton gestation iron deficiency anemia defined as maternal serum ferritin levels less than 15 microgramsdL and planned delivery at Miami Valley Hospital Exclusion criteria consist of vitamin C use 150mgday typical prenatal vitamin contains 60mg Vitamin C diabetes gestational types 12 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 All risksbenefits will be reviewed and all questions answered prior to the patient being enrolled Written informed consent will be obtained by a study investigator or qualified personnel Gestational dating will be based upon the best obstetrical estimate
B A compounding pharmacy will make 30000 placebo capsules containing an inert substance ie silica based cellulose identical appearing to 30000 capsules of 500mg vitamin C The pharmacy will package 300 pills of either placebo or vitamin C into 200 boxes labeled only with the project name and a number A key containing the known substance of each box and number will be kept by the pharmacy until the end of the study The boxes will be stored in a secured area of the principal investigators office The boxes will be taken to Five Rivers Womens Health Clinic to be distributed to enrolled patients Once enrolled patients will be given a random box and instructed to take 1 pill twice daily Patients will be instructed to record pill usage daily for compliance The patients name and assigned box number will be kept in a locked cabinet At the end of the study the two keys will be compared to determine who received placebo or vitamin C Both groups will receive prescriptions for ferrous sulfate 65mg taken once daily docusate sodium to be taken as needed for constipation and prenatal vitamins once daily Patients will receive follow up labs as part of the standard of care for anemia to include at 28 week and at delivery All data will be collected in an Excel spreadsheet with patient identifiers removed Data will be analyzed by applying basic T tests and the Mann-Whitney-U test to determine the changes in lab values of hemoglobin hematocrit iron transferrin ferritin between experimental and control before and after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None