Relative Bioavailability of Iron and Folic Acid in New Test Supplement
This study has been completed.
Sponsor:
University of Toronto
Collaborators:
The Hospital for Sick Children
H.J Heinz Foundation
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00789490
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Iron Deficiency Folic Acid Deficiency |
Dietary Supplement: Daminaide 995 - SuppleFem Sprinkles Dietary Supplement: Materna |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Relative Bioavailability of Iron and Folic Acid From a New Powdered Supplement Compared to a Traditional Tablet in Pregnant Women |
Resource links provided by NLM:
Further study details as provided by University of Toronto:
Primary Outcome Measures:
- 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. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary outcome is a comparison of area under the curve (AUC) for change in serum folate for each intervention [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | October 2005 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Dietary Supplement: Daminaide 995 - SuppleFem Sprinkles
The study agent SuppleFem will be a preblend manufactured by Acatris in Oakville Ontario and will be repackaged into 1 gram aliquots in white plastic Tamper Seal Vials.1 ram to be taken with test meal
Dietary Supplement: Materna
Materna is a pregnancy supplement available on the Canadian market and is manufactured by Wyeth. Dose is 1 tablet per day
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
No publications provided by University of Toronto
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Stanley Zlotkin M.D, PhD, FRCP (C), The Hospital For Sick Children |
| ClinicalTrials.gov Identifier: | NCT00789490 History of Changes |
| Other Study ID Numbers: | Sickkids REB 1000007811 |
| Study First Received: | November 12, 2008 |
| Last Updated: | November 12, 2008 |
| Health Authority: | Canada: Health Canada Natural Health Products Directorate |
Keywords provided by University of Toronto:
|
pregnancy relative bioavailability iron |
folic acid ferric pyrophosphate Study focus is to compare the relative bioavailability of SuppleFem Sprinkles to the current tradtional tablet Materna in pregnant women |
Additional relevant MeSH terms:
|
Folic Acid Deficiency Anemia, Iron-Deficiency Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders |
Metabolic Diseases Folic Acid Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013