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Relative Bioavailability of Iron and Folic Acid in New Test Supplement

NCT00789490 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2008-11-13

No results posted yet for this study

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 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER

  • Heinz Endowments

    collaborator OTHER

  • University of Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00789490 on ClinicalTrials.gov