Trial document




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  DRKS00009770

Trial Description

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Title

Effect of multimicronutrient supplementation on vitamin D status in women of childbearing age

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Trial Acronym

BTS917/15

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URL of the Trial

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Brief Summary in Lay Language

Sufficient Vitamin-D and folate supply is important for a normal course of pregnancy. Vitamin D is required to promote skeletal development and neonatal health. Folat plays an important role for the normal development of the foetal spine, brain and scull especially during early pregnancy - i.e. the first weeks during the time where women partially do not know about their pregnancy. A timely supplementation with Vitamin D and folat prior getting pregnant is desirable.
The aim of the study is to investigate the Vitamin-D and folate status after 8 weeks of supplementation with two multi-micro-nutrients targeted for the time period when women of child-bearing age want to become pregnant.

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Brief Summary in Scientific Language

The aim of the current study is to investigate the effects of Femibion® 1 on vitamin D and folate status in comparison to Elevit® gynvital in healthy women of childbearing age.
The relative increase of 25(OH)D in healthy women of childbearing age will be assessed. Primary objective is to determine if there is a significant difference in relative increase in 25(OH)D serum levels between the two products over a supplementation period of 8 weeks.

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Organizational Data

  •   DRKS00009770
  •   2016/01/05
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  •   no
  •   Approved
  •   F-2015-102, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   healthy volunteers
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Interventions/Observational Groups

  •   Femibion® 1, 800 µg Folic acid/ Metafolin, 20 µg / 800 IU Vitamin D per day p.o. (tablet), 8 weeks
  •   Elevit®gynvital , 400 µg Folic acid/ Metafolin, 5 µg / 200 IU Vitamin D per day p.o. (capsule), 8 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The relative increase of 25(OH)D in healthy women of childbearing age will be assessed.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/01/08
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   45   Years
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Additional 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

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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

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Addresses

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    • Merck Selbstmedikation GmbH
    • Frankfurter Straße 250
    • 64293  Darmstadt
    • Germany
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    • Merck Selbstmedikation GmbH
    • Ms.  Dr.  Lieselotte  Krug 
    • Frankfurter Straße 250
    • 64293  Darmstadt
    • Germany
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    • BioTeSys GmbH
    • Ms.  Christiane  Schön 
    • Schelztorstr. 54-56
    • 73728  Esslingen
    • Germany
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Sources of Monetary or Material Support

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    • Merck Selbstmedikation GmbH
    • Frankfurter Straße 250
    • 64293  Darmstadt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/09
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Trial Publications, Results and other Documents

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