healthy volunteers
Conditions
Interventions
Group 1: Femibion® 1, 800 µg Folic acid/ Metafolin, 20 µg / 800 IU Vitamin D per day p.o. (tablet), 8 weeks
Group 2: Elevit®gynvital , 400 µg Folic acid/ Metafolin, 5 µg / 200 IU Vitamin D per day p.o
Sponsors
Merck Selbstmedikation GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Subject is able and willing to sign the Informed Consent Form prior to screening evaluations 2) Healthy volunteers: Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry and haematology 3) Women of childbearing age 4) Age = 18 and = 45 years 5) BMI: 17-30 kg/m2 6) No travel into southern countries in the past 30 days 7) No plans to travel into southern countries during the study 8) Able and willing to follow the study protocol procedures
Exclusion criteria
Exclusion criteria: 1) For this study clinically relevant abnormal, vital signs or physical findings at screening and abnormal laboratory finding at visit 1 2) Taking any medication interfering with vitamin D metabolism, e.g. cardiac glycosides, barbitu-rates, anti-tuberculosis drugs (rifampicin, isoniazid), cholestyramine, glucocorticoids (except inhalative), benzothiadiazine derivates, anti-convulsants, PTH or PTH derivates in the past 6 months 3) Vitamin D prescription 4) Intake of the antibiotics Pyrimethamin or Trimethoprim two weeks prior to visit 1 as both anti-biotics interfere with the folate metabolism. 5) Taking other dietary supplements/medication with folate and/or vitamin D in the past 2 months. 6) Concomitant use of cod liver oil or intake during the past 2 months 7) Because of thyroid disorder intake of iodine contraindicated 8) Sarcoidosis or any other granuloma-forming inflammatory disease 9) Osteoporosis, Osteomalacia 10) History of diabetes, stroke, CVD, cancer 11) Fat malabsorption (Crohn’s or celiac disease, cystic fibrosis) 12) Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s IBS, IBD, peptic ulcers) hinder-ing Vit. D absorption 13) Liver or renal disease (including alcoholism) 14) Pancreatic insufficiency (disturbed fat metabolism) 15) Ca kidney stones or history of hypercalcaemia and hypercalciuria 16) Psychological disorders 17) Calcium metabolism disorders 18) Hypo-& and Hyperparathyroidism 19) Participants anticipating a change in their lifestyle or physical activity levels during the study. 20) Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study. 21) Known hypersensitivity to the study preparation or to single ingredients (e.g. allergy to crus-taceans or fish) 22) Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject. 23) Known HIV-infection 24) Known acute or chronic hepatitis B and C infection 25) Blood donation within 4 weeks prior to visit 1 or during the study. 26) Subject involved in any clinical or food study 4 weeks prior to visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The relative increase of 25(OH)D in healthy women of childbearing age will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of 25(OH)D levels from baseline to 4 weeks compared between products Change of RBC-folate from baseline to 4 and 8 weeks compared between products Change of serum folate from baseline to 4 and 8 weeks compared between products Change of homocysteine (Hcy) from baseline to 4 and 8 weeks compared between products Amount of responder volunteers defined as volunteers reaching 25(OH)D levels above =50 nmol/L or =75 nmol/L after 4 and 8 weeks of supplementation compared between products. Amount of responder volunteers defined as volunteers reaching RBC folate levels > 1000 nmol/L after 4 and 8 weeks of supplementation compared between products. Amount of responder volunteers defined as volunteers reaching homocysteine levels <8 µmol/L after 4 and 8 weeks of supplementation compared between products. Within group changes of primary and secondary variables are investigated. | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed