Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum
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ClinicalTrials.gov Identifier: NCT04284696 |
Recruitment Status : Unknown
Verified February 2021 by Alex Farr, MD PhD, Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : February 26, 2020
Last Update Posted : February 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperemesis Gravidarum Nausea Gravidarum Vitamin C Deficiency | Dietary Supplement: Pregnan-C-Gum(R) chewing gum Dietary Supplement: Placebo chewing gum | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 111 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum: a Randomized Controlled Trial |
Actual Study Start Date : | February 11, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | March 31, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Verum
patients with emesis gravidarum who take a chewing gum with vitamin C (verum) "ad libitum" several times daily for 2 weeks
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Dietary Supplement: Pregnan-C-Gum(R) chewing gum
Using a chewing gum with 150mg vitamin C (per piece/gum) for 14 days "ad libitum" |
Placebo Comparator: Placebo
patients with emesis gravidarum who take chewing gum without vitamin C (placebo) "ad libitum" several times daily for 2 weeks
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Dietary Supplement: Placebo chewing gum
Using a chewing gum without vitamin C (per piece/gum) for 14 days "ad libitum" |
No Intervention: Nihil
patients with emesis gravidarum who do not use chewing gum during the study phase
|
- Modified PUQE (Pregnancy-Unique Quantification of Emesis and Nausea) Score [ Time Frame: 1 month ]validated questionnaire describing individual nausea
- Level of diamine oxidase (DAO) serum concentratlon [ Time Frame: 1 month ]maybe an antidot of nausea and vomiting
- Level of histamine serum concentration [ Time Frame: 1 month ]maybe a cause of nausea and vomiting
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | pregnancy |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age ≥18 years
- singleton pregnancy
- signed information sheet
- symptoms of nausea and / or vomiting in early pregnancy
- no pre-existing medication for nausea and vomiting
Exclusion criteria:
- age <18 years
- multiple pregnancy
- patients with gastric band or in Z.n. bariatric surgery
- preexisting diabetes mellitus or gestational diabetes
- inability to consent to participation in the study
- already started therapy against the emesis gravidarum
- taking any antiemetic drugs during the study phase
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): NCT04284696
Contact: Alex Farr, MD PhD | +4314040028220 | alex.farr@meduniwien.ac.at | |
Contact: Philipp Foessleitner, MD BSc | +4314040028220 | philipp.foessleitner@meduniwien.ac.at |
Austria | |
Medical University of Vienna, Dept. of Obstetrics and Gynecology | Recruiting |
Vienna, Austria, 1090 | |
Contact: Philipp Foessleitner, MD BSc +43140400 ext 28220 philipp.foessleitner@muv.ac.at | |
Contact: Alex Farr, MD PhD +43140400 ext 28220 alex.farr@muv.ac.at |
Principal Investigator: | Alex Farr, MD PhD | Medical University of Vienna, Department of Obstetrics and Gynecology; Vienna General Hospital |
Responsible Party: | Alex Farr, MD PhD, Assistant Professor, Consultant Physician, Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT04284696 |
Other Study ID Numbers: |
1949-2019 |
First Posted: | February 26, 2020 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hyperemesis Gravidarum Scurvy Ascorbic Acid Deficiency Signs and Symptoms, Digestive Morning Sickness Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Vomiting |
Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Hematologic Diseases |