Iron Supplementation During Pregnancy - One Versus Two Ferrous Sulfate Capsules for Iron Deficient Pregnant Women

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Since normal pregnancies are associated with dilutional anemia, due to a greater increase in plasma volume with a smaller increase in RBC mass, it is important to properly diagnose IDA according to the levels of serum ferritin. Previous studies examining the optimal iron dose have shown that adjustment of iron supplementation according to serum ferritin levels in early pregnancy could be beneficial. Nonetheless, there is no consensus regarding the appropriate dose of iron during pregnancy, its dose-response curve and its effect on serum ferritin levels.

In this trial the investigators sought to assess the efficacy of doubling the daily iron supplement dose in pregnant women with IDA.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assuta Hospital Systems
• Treatments: Iron

Criteria

Inclusion Criteria:

1. Healthy pregnant women ages 18-42

2. A diagnosis of iron deficiency anemia (defined as a hemoglobin concentration <10.5 g/dL and ferritin levels < 15 ng/ml) between 16-19 weeks

3. Full access to medical computerized files.

Exclusion Criteria:

1. Hyperemesis gravidarum continuing past 20 weeks of gestation

2. Thalassemia

3. Abnormal blood smears

4. Vitamin D deficiency

5. Mal-absorption disorders (inflammable bowel diseases; Crohn's, Ulcerative Colitis)

6. Chronic diseases associated with anemia (i.e SLE).

7. Deterioration in hemoglobin levels mandating IV iron administration

8. More than 3 capsules missed at the 2 weeks check-up

9. diarrhea lasting more than 5 days

10. Vomiting lasting more than 5 days less than 2 hours after supplement ingestion

11. Administration of blood products during pregnancy

12. Use of multi-vitamin supplements containing iron

13. Hospitalization periods greater than two weeks

14. A time period shorter than 15 weeks from allocation to delivery -