Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Multivitamin Supplementation to Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300155
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Collaborator:
Duchesnay Inc.
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children

Brief Summary:
The purpose of this study is to compare the tolerability of Pregvit® to a common prenatal vitamin (Orifer® F) among pregnant women with morning sickness or those suffering from a variety of conditions.

Condition or disease Intervention/treatment Phase
Pregnancy Morning Sickness Nausea Vomiting Hyperemesis Gravidarum Drug: Pregvit® Drug: Orifer F® Phase 4

Detailed Description:

Presently, there is a large choice of perinatal vitamins on the market. Materna® is taken by 70% of Canadian women. A recent study by the investigators team has shown that up to 35%-53% of women with moderate to severe morning sickness discontinue their Materna®. One main reason is that its large size causes difficulties in swallowing, which prompts women to stop taking the drug. The second main reason for stopping is gastrointestinal adverse effects from the iron content, which causes nausea, vomiting and constipation.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Multivitamin Supplementation to Pregnant Women
Study Start Date : October 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PregVit®
Women will be randomized to the '35 mg' group, who will start supplementation with PregVit® (low iron content, small size)
Drug: 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
Other Name: Dietary supplement-prenatal multivitamin

Active Comparator: Orifer F®
Women will be randomized to the '60 mg' group, who will start supplementation with Orifer F® (high iron content, small size).
Drug: 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 Name: Dietary supplement-prenatal multivitamin




Primary Outcome Measures :
  1. The difference in rates of ability to take multivitamin [either Pregvit® or Orifer®F] [ Time Frame: Study completion was defined as completing monthly telephone interviews (when possible) to document pill intake and adverse events up until the end of pregnancy (i.e. 36 weeks gestation or further). ]
    Rates of adherence and adverse events will be compared by using chi-squared tests, as appropriate. Adherence will be also compared between the 2 treatment groups through Kaplan-Meier survival curves in 2 ways. The first survival curve analysis will compare the proportion of women with standard adherence (i.e. at least 80% pill intake over time), after having commenced supplementation with the assigned multivitamin, and the p-value was determined by the Wilcoxon (Peto-Prentice) test.


Secondary Outcome Measures :
  1. The overall use of Pregvit® vs Orifer®F (adherence) [ Time Frame: Study completion was defined as completing monthly telephone interviews (when possible) to document pill intake and adverse events up until the end of pregnancy (i.e. 36 weeks gestation or further). ]
    Rates of adherence and adverse events will be compared by using chi-squared tests, as appropriate. Adherence will be also compared between the 2 treatment groups through Kaplan-Meier survival curves in 2 ways. The second survival curve analysis will compare overall adherence among women who commenced supplementation with the assigned multivitamin, at any percentage of pill intake over time, and the p-value was determined by the log rank statistic. All curves will be plotted from the coordinates of 100% (y-axis point of 1.0) at time zero (x-axis point of 0) to represent that at the beginning of the study, all subjects who commenced supplementation in each multivitamin group were adherent.

  2. The rates of overall adverse events and specific side effects between the two groups [ Time Frame: Study completion was defined as completing monthly telephone interviews (when possible) to document pill intake and adverse events up until the end of pregnancy (i.e. 36 weeks gestation or further). ]
    Rates of adherence and adverse events will be compared by using chi-squared tests, as appropriate.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Any woman who discontinued her standard vitamins due to gastrointestinal symptoms or due to the tablet size, with one ofthe following conditions:

  • 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 who do not agree to consent to this protocol.
  • Women with a known hypersensitivity to any of the ingredients of Pregvit®, or Orifer® F.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300155


Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Duchesnay Inc.
Investigators
Layout table for investigator information
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children, Toronto Canada

Additional Information:
Layout table for additonal information
Responsible Party: Gideon Koren, Director of MotherRisk Program, Clinical Pharmacology and Toxicology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02300155     History of Changes
Other Study ID Numbers: 1000005135
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2014

Keywords provided by Gideon Koren, The Hospital for Sick Children:
Pregnancy
Morning Sickness
nausea and vomiting
hyperemesis gravidarum
perinatal vitamins

Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperemesis Gravidarum
Morning Sickness
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Pregnancy Complications