O21.0
Conditions
Interventions
Group 1: Nutrient preparation, per day 21.0 mg vitamin B6, 6.0 mg vitamin B1 and 12.0 µg vitamin B12 (3x daily a lozenge), for two weeks
Group 2: Nutrient preparation, per day 1.2 mg vitamin B6 (3x d
Sponsors
Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women with confirmed pregnancy to the end of the 10th week of pregnancy, acute nausea during pregnancy (Nausea gravidarum)
Exclusion criteria
Exclusion criteria: deterioration of nausea gravidarium during the study period of two weeks; intake of vitamin B6 supplements over 2 mg/day; taking any medications against nausea and vomiting; previous hospitalization due to nausea gravidarum; BMI =30kg/m2; Blood pressure: >160mmHg systolic or >100mmHg diastolic; multiple pregnancy; known complications in an earlier pregnancy (e.g. premature delivery, miscarriage, placental abnormalities, fetal anomaly); severe chronic illness (manifest coronary heart disease, cancer); insulin-dependent diabetes mellitus Typ I and II; severe kidney or liver diseases; conditions after gastrointestinal surgical procedure and chronic gastrointestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas), e.g. gastrectomy, celiac diseases, chronic pancreatitis, cholestasis, short bowel syndrome, chronic inflammatory bowel disease (except appendicitis, gallstone surgery); hormonal disorders, for example, Cushing's syndrome and untreated hyperthyroidism; addiction (alcohol, drugs and/or medications); missing consent; refusing / reset of the consent; simultaneous participation in another clinical trial or participation within the last 30 days; planned surgery within the next three month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| nausea gravidarium measured by PUQE-Score (pregnancy-unique quantification of emesis and nausea) at the beginning of the study, during the study (daily for 14 days) and at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| nausea gravidarium measured by visual analogue scale at the beginning of the study, during the study (daily for 14 days) and at the end of the study. Vitamin B6 plasma concentration at the beginning and end of the study. | — |
Countries
Germany
Contacts
Public ContactKatharina Möller
Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Outcome results
None listed