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NCT03501290: OFraDDom
Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.
NA trial testing Fortimel® Protein supplementation in Frail Elderly in 62 participants. Completed in 31 December 2019.
31 December 2019
Quick facts
| Lead sponsor | University Hospital, Toulouse |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 62 |
| Start date | 1 June 2016 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- Fortimel® Protein supplementation
Conditions studied
- Frail Elderly — all drugs for Frail Elderly →
Sponsor
University Hospital, Toulouse
Who can join
65 and older, any sex, with Frail Elderly. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, patients are supposed to take Fortimel® Protein, an Oral Nutritional Supplement (ONS) recommended in case of malnutrition once daily during the study period. Three visits will be planned for each patient enrolled in the study (baseline visit, visits of follow-up at 4 weeks and 12 weeks). Phone calls will be regularly organized during one month or three months according to the duration of supplementation. The primary purpose of the OFraDDom study is to assess the compliance with ONS (respect by the patient of the physician's prescription) at the end of the first month. Data regarding the beneficial effects of ONS, or compliance with ONS in frail elderly population, are very limited. The study could complete knowledge about oral nutritional supplementation in the undernourished frail elderly people and help to demonstrate that oral nutritional supplements have benefits on nutritional status and physical performances in frail elderly people.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03501290
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Toulouse trials
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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 NCT03501290 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Toulouse
- Last refreshed: 25 August 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/NCT03501290.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing