Improving Multivitamin Supplementation to Pregnant Women
NCT ID: NCT02300155
Last Updated: 2014-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1370 participants
INTERVENTIONAL
2004-10-31
2008-01-31
Brief Summary
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Detailed Description
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A new periconceptional multivitamin supplement, Pregvit®, was introduced to the market in September 2003 by the Canadian company Duchesnay Inc. with the aim of trying to overcome the disadvantages of the existing multivitamin supplements. PregVit® is a prenatal multivitamin that contains 35 mg elemental iron, as ferrous fumarate. It is formulated into 2 small tablets (each tablet:16 mm × 9 mm × 4 mm), containing different vitamins and minerals, particularly separating the iron (morning tablet) from the calcium (evening tablet) to optimize iron absorption. The use of PregVit® requires a physician's prescription.
Since Materna® or other generic products are the most commonly used non-prescription (i.e. over-the-counter) prenatal multivitamins, they were not selected for comparison in the study because enrolled subjects who had discontinued a prenatal multivitamin most likely had discontinued any one of them. Ethically, subjects in this situation cannot be randomized to resume Materna® or another generic prenatal multivitamin.
Instead, Orifer F® was selected as the small-tablet prenatal multivitamin (one tablet: 5 mm radius, 5 mm thickness), containing a high iron content (60 mg elemental iron as ferrous sulphate). It is taken daily as a single tablet and the use of Orifer F® does not require a physician prescription (i.e. over-the-counter).
Comparing tolerability of PregVit® to Orifer F® would address separation of the potential effect of iron content from that of tablet size on multivitamin tolerability among pregnant women and women suffering from morning sickness or those suffering from a variety of conditions such as, Crohn's Disease, Ulcerative Colitis, Peptic-Duodenal Ulcer, Irritable Bowel Syndrome, Celiac Disease, as well as anemia or hypothyroidism.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PregVit®
Women will be randomized to the '35 mg' group, who will start supplementation with PregVit® (low iron content, small size)
Pregvit®
Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing -twice daily for '35 mg' group
Orifer F®
Women will be randomized to the '60 mg' group, who will start supplementation with Orifer F® (high iron content, small size).
Orifer F®
Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing-once daily for '60 mg' group
Interventions
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Pregvit®
Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing -twice daily for '35 mg' group
Orifer F®
Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing-once daily for '60 mg' group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Morning sickness.
* Gastrointestinal disorders: Crohn's disease, ulcerative colitis, peptic or duodenal ulcer, irritable colon, celiac disease.
* Iron deficiency anemia.
* Hypothyroidism.
* Depression.
Exclusion Criteria
* Women with a known hypersensitivity to any of the ingredients of Pregvit®, or Orifer® F.
18 Years
50 Years
FEMALE
No
Sponsors
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Duchesnay Inc.
INDUSTRY
The Hospital for Sick Children
OTHER
Responsible Party
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Gideon Koren
Director of MotherRisk Program, Clinical Pharmacology and Toxicology
Principal Investigators
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Gideon Koren, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Related Links
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Effect of iron content on the tolerability of prenatal multivitamins in pregnancy
Adherence and tolerability of iron-containing prenatal multivitamins in pregnant women with pre-existing gastrointestinal conditions.
Other Identifiers
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1000005135
Identifier Type: -
Identifier Source: org_study_id