Not provided
Not provided
Not provided
Not provided
Not provided
Unable to recruit enough participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.
Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily iron supplementation | Active Comparator | Oral ferrous sulfate, 325 mg, take once daily |
|
| Alternate day iron supplementation | Experimental | Oral ferrous sulfated, 650mg, taken once daily every other day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate | Drug | Iron supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Hemoglobin Levels From Enrollment to End of Study | Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy | Baseline and again 8-9 months later (third trimester of pregnancy) |
| Change in Hematocrit in the Third Trimester After Treatment | Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy | Baseline and again 8-9 months later (third trimester of pregnancy) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Side Effects After 2-4 Weeks of Treatment | Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire. | 2-4 weeks after enrollment |
| Complete Blood Count in the Third Trimester |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melody Safarzadeh, MD, MS | UTMB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
The protocol was terminated early due to low accrual.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Daily Iron Supplementation | Oral ferrous sulfate, 325 mg, take once daily Ferrous sulfate: Iron supplementation |
| FG001 | Alternate Day Iron Supplementation | Oral ferrous sulfated, 650mg, taken once daily every other day Ferrous sulfate: Iron supplementation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daily Iron Supplementation | Oral ferrous sulfate, 325 mg, take once daily Ferrous sulfate: Iron supplementation |
| BG001 | Alternate Day Iron Supplementation | Oral ferrous sulfated, 650mg, taken once daily every other day Ferrous sulfate: Iron supplementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Hemoglobin Levels From Enrollment to End of Study | Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy | No data collected due to early termination. | Posted | Baseline and again 8-9 months later (third trimester of pregnancy) |
|
No data collected due to early termination.
No data collected due to early termination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daily Iron Supplementation | Oral ferrous sulfate, 325 mg, take once daily Ferrous sulfate: Iron supplementation |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melody Safarzadeh | University of Texas Medical Branch Galveston | 9082854962 | mesafarz@utmb.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2023 | Mar 28, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery
| 8-9 months after enrollment (third trimester of pregnancy) |
| Serum Ferritin at Time of Enrollment | Serum ferritin will assessed by blood draw at time of enrollment. | Baseline only at time of enrollment |
| Total Iron Binding Capacity at Time of Enrollment | Total iron binding capacity will assessed by blood draw at time of enrollment. | Baseline only at time of enrollment |
| Transferrin at Time of Enrollment | Transferrin levels will assessed by blood draw at time of enrollment. | Baseline only at time of enrollment |
| Number of Participants Who Receive Intravenous (IV) Iron Supplementation | By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia | At completion of study, on average after 9 months |
| Number of Participants Who Receive a Blood Transfusion | By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia | At completion of study, on average after 9 months |
| Postpartum Hemoglobin | Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care) | At completion of study, on average after 9 months |
| Postpartum Hematocrit | Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care) | At completion of study, on average after 9 months |
| Neonatal Weight at Delivery | The weight of the baby (in grams) will be determined by chart review at the end of enrollment | At completion of study, on average after 9 months |
| Level of Neonatal Bilirubin at Birth | Neonatal hyperbilirubinemia will be reviewed and recorded by chart review | At completion of study, on average after 9 months |
| Neonatal Apgar Scores | Neonatal Apgar scores will be reviewed and recorded by chart review. The Apgar score is a method used to describe a newborn's status at birth and response to resuscitation. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The range of scores is 0 to 10. Higher scores indicate reassuring newborn status. | At completion of study, on average after 9 months |
| Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU). | The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed | At completion of study, on average after 9 months |
| Weight Class at Time of Enrollment | At time of enrollment the weight of the subject will be assessed and assigned a weight class using the World Health Organization weight classification | Baseline only at time of enrollment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Change in Hematocrit in the Third Trimester After Treatment | Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy | No data collected due to early termination. | Posted | Baseline and again 8-9 months later (third trimester of pregnancy) |
|
|
| Secondary | Gastrointestinal Side Effects After 2-4 Weeks of Treatment | Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire. | No data collected due to early termination. | Posted | 2-4 weeks after enrollment |
|
|
| Secondary | Complete Blood Count in the Third Trimester | Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery | No data collected due to early termination. | Posted | 8-9 months after enrollment (third trimester of pregnancy) |
|
|
| Secondary | Serum Ferritin at Time of Enrollment | Serum ferritin will assessed by blood draw at time of enrollment. | No data collected due to early termination. | Posted | Baseline only at time of enrollment |
|
|
| Secondary | Total Iron Binding Capacity at Time of Enrollment | Total iron binding capacity will assessed by blood draw at time of enrollment. | No data collected due to early termination. | Posted | Baseline only at time of enrollment |
|
|
| Secondary | Transferrin at Time of Enrollment | Transferrin levels will assessed by blood draw at time of enrollment. | No data collected due to early termination. | Posted | Baseline only at time of enrollment |
|
|
| Secondary | Number of Participants Who Receive Intravenous (IV) Iron Supplementation | By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Number of Participants Who Receive a Blood Transfusion | By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Postpartum Hemoglobin | Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care) | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Postpartum Hematocrit | Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care) | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Neonatal Weight at Delivery | The weight of the baby (in grams) will be determined by chart review at the end of enrollment | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Level of Neonatal Bilirubin at Birth | Neonatal hyperbilirubinemia will be reviewed and recorded by chart review | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Neonatal Apgar Scores | Neonatal Apgar scores will be reviewed and recorded by chart review. The Apgar score is a method used to describe a newborn's status at birth and response to resuscitation. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The range of scores is 0 to 10. Higher scores indicate reassuring newborn status. | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU). | The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed | No data collected due to early termination. | Posted | At completion of study, on average after 9 months |
|
|
| Secondary | Weight Class at Time of Enrollment | At time of enrollment the weight of the subject will be assessed and assigned a weight class using the World Health Organization weight classification | No data collected due to early termination. | Posted | Baseline only at time of enrollment |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Alternate Day Iron Supplementation | Oral ferrous sulfated, 650mg, taken once daily every other day Ferrous sulfate: Iron supplementation | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |