Status:
COMPLETED
Relative Bioavailability of Iron and Folic Acid in New Test Supplement
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
The Hospital for Sick Children
Heinz Endowments
Conditions:
Iron Deficiency
Folic Acid Deficiency
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the fetus, thus supplements are recommended. Adherence to current tablet-based supplements is documented to be poo...
Detailed Description
Background: The proposal addresses the issue of the bioavailability of the supplement SuppleFem as compared to the current standard supplement Materna during pregnancy in Canadian women. In recogniti...
Eligibility Criteria
Inclusion
- Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age).
- Normal Hb (Hb≥110g/L and Hb≤144g/L)
Exclusion
- Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases)
- A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative colitis
- A history of or current use of IV iron therapy or erythropoietin therapy
- A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid
- Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia, etc.
- Current acute illness and/or taking antibiotics
- Known or suspected allergies to Materna®, or any ingredient present in Materna or SuppleFem Sprinkles or any of the foods to be consumed during the trial.
- Mildly to severely anemic women (Hb\<110 g/L) or elevated hemoglobin (above 144g/L)
- Complications in pregnancy (including pregnancy induced hypertension, preeclampsia, a history of severe antepartum hemorrhage)
- Blood transfusion within last 3 months
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00789490
Start Date
October 1 2005
End Date
July 1 2006
Last Update
November 13 2008
Active Locations (1)
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1
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8