Iron Deficiency Clinical Trial
Official title:
Relative Bioavailability of Iron and Folic Acid From a New Powdered Supplement Compared to a Traditional Tablet in Pregnant Women
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 poor. Recently a powdered form of micronutrients has been developed which may decrease side-effects and thus improve adherence. However, before testing the efficacy of the supplement as an alternate choice for supplementation during pregnancy, the bioavailability of the iron needs to be determined. The objective of this study is to measure the relative bioavailability of iron and folic acid from a powdered supplement that can be sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant women.
Status | Completed |
Enrollment | 18 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: 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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital For Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | H.J Heinz Foundation, The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is a comparison of area under the curve (AUC) for change in serum iron for each intervention adjusted for diurnal variation. The use of AUC will provide a single outcome for each participant. | 3 weeks | No | |
Secondary | The secondary outcome is a comparison of area under the curve (AUC) for change in serum folate for each intervention | 2 weeks | No |
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