Last reviewed · How we verify
NCT04462939
Study to Learn About the Effect of Elevit (a Food Supplement Containing Several Vitamins, Minerals, Lutein and DHA) on the Nutrient Content in the Breast Milk and Blood of Women During Breastfeeding Period and on Babies' Physical Growth Parameters
NA trial testing Elevit Breastfeeding & Postnatal Care in Healthy Lactating Mother in 68 participants. Completed in 12 November 2019.
12 November 2019
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 68 |
| Start date | 26 April 2017 |
| Primary completion | 12 November 2019 |
| Estimated completion | 12 November 2019 |
| Sites | 3 locations across Germany |
Drugs / interventions tested
- Elevit Breastfeeding & Postnatal Care
- Placebo
Conditions studied
- Healthy Lactating Mother — all drugs for Healthy Lactating Mother →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 45, female only, with Healthy Lactating Mother. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA supplementation (Elevit Breastfeeding \& Postnatal Care) on the breast milk nutrient composition and babies physical growth parameters. Mothers participating in this study received either Elevit or placebo orally once a day for 12 weeks starting from 4 to 6 weeks after delivery. Blood, urine and milk samples were collected from the mothers and physical parameters like size and weight were collected from the babies to assess the effect of the supplementation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Multiple Micronutrients, Lutein, and Docosahexaenoic Acid Supplementation during Lactation: A Randomized Controlled Trial.
Schaefer E, Demmelmair H, Horak J, Holdt L, et al · · 2020 · cited 12× · PMID 33339438 · DOI 10.3390/nu12123849
Verify or expand the search:
- PubMed search for NCT04462939
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04462939 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 8 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04462939.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing