Relative Bioavailability of Iron and Folic Acid in New Test Supplement

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789490

Locations
Canada, Ontario
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
University of Toronto
The Hospital for Sick Children
H.J Heinz Foundation
  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
Folic Acid
Vitamin B Complex
Anemia, Iron-Deficiency
Anemia
Anemia, Hypochromic
Avitaminosis
Deficiency Diseases
Hematologic Diseases
Iron Metabolism Disorders
Malnutrition
Metabolic Diseases
Nutrition Disorders
Vitamin B Deficiency
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014