Improving Multivitamin Supplementation to Pregnant Women

NCT02300155 | Completed Phase 4 DMC

• 1 other identifier: 1000005135
• Study Type: interventional
• Target: 1,370
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Morning Sickness; Nausea; Vomiting; Hyperemesis Gravidarum

Keywords

Pregnancy; Morning Sickness; nausea and vomiting; hyperemesis gravidarum; perinatal vitamins

Outcome Measures

Primary Outcomes (1)

• The difference in rates of ability to take multivitamin [either Pregvit® or Orifer®F]

  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.

  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).

Secondary Outcomes (2)

• The overall use of Pregvit® vs Orifer®F (adherence)

  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).

• The rates of overall adverse events and specific side effects between the two groups

  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).

Study Arms (2)

PregVit®

EXPERIMENTAL

Women will be randomized to the '35 mg' group, who will start supplementation with PregVit® (low iron content, small size)

Drug: Pregvit®

Orifer F®

ACTIVE COMPARATOR

Women will be randomized to the '60 mg' group, who will start supplementation with Orifer F® (high iron content, small size).

Drug: Orifer F®

Interventions

Pregvit® DRUG

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

Also known as: Dietary supplement-prenatal multivitamin

PregVit®

Orifer F® DRUG

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

Also known as: Dietary supplement-prenatal multivitamin

Orifer F®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Duchesnay Inc.: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

• 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.

MeSH Terms

Conditions

Morning Sickness; Nausea; Vomiting; Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gideon Koren, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MotherRisk Program, Clinical Pharmacology and Toxicology

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: October 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: January 1, 2008
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

CA (1)