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NCT04041492
Effect of Vitamins D3 and K2 in uOc and Insulin Serum Levels in Patients With Diabetes Mellitus
NA trial testing Supplementation with Vitamin D3 y K2 in Diabetes Mellitus, Type 2 in 100 participants. Completed in 14 February 2019.
14 February 2018
Quick facts
| Lead sponsor | University of Guadalajara |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 100 |
| Start date | 14 February 2017 |
| Primary completion | 14 February 2018 |
| Estimated completion | 14 February 2019 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Supplementation with Vitamin D3 y K2
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Bone Loss — all drugs for Bone Loss →
- Insulin Resistance — all drugs for Insulin Resistance →
Sponsor
University of Guadalajara
Who can join
Adults 30 to 75, any sex, with Diabetes Mellitus, Type 2 or Bone Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction: Patients with DM2 have chronic hyperglycemia derived from a decrease in insulin sensitivity, cause of comorbidities such as bone demineralization, decreasing quality of life and increasing mortality. This could be related to changes in the serum levels of carboxylated Osteocalcin and Insulin, together with the deficit the daily consumption of vitamins D3 and K, which is crucial for the process of mineralization of the bone matrix. Research question: What is the effect of supplementation with Vitamins D3 and K2 on serum levels of Carboxylated Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus? Hypothesis: Supplementation with Vitamins D3 and K2 modifies the serum levels of Carboxylated Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus. General Objectives: To assess the effect of supplementation with Vitamins D3 and K2 on serum levels of Carboxylated and Non-Carboxylated Osteocalcin in patients with Type 2 Diabetes mellitus. Material and Methods: Clinical trial, double blind, randomization, 40 patients with DM2, 35-65 years, supplementation (3 months), clinical and laboratory determinations (uOC and Insulin). * Group 1: Vitamin D3 1000UI + Placebo * Group 2: Vitamin K2 100 mcg + Placebo * Group 3 (Positive Control): Vitamins D3 1000UI + K2 100 mcg
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular Pathways and Roles for Vitamin K2-7 as a Health-Beneficial Nutraceutical: Challenges and Opportunities.
Jadhav N, Ajgaonkar S, Saha P, Gurav P, et al · · 2022 · cited 52× · PMID 35774605 · DOI 10.3389/fphar.2022.896920 -
Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients with type 2 diabetes mellitus: a randomized, double-blind, clinical trial.
Aguayo-Ruiz JI, García-Cobián TA, Pascoe-González S, Sánchez-Enríquez S, et al · · 2020 · cited 21× · PMID 32831908 · DOI 10.1186/s13098-020-00580-w -
EXPRESS: Association between the VKORC1 rs8050894 CC genotype and ucOC levels following vitamin K and D supplementation in Mexican Citizens with T2DM: a randomized clinical trial.
Salinas-Varela Y, Barajas-González MA, Martínez-López E, Llamas-Covarrubias IM, et al · · 2026 · PMID 42257367 · DOI 10.1177/10815589261460882
Verify or expand the search:
- PubMed search for NCT04041492
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Guadalajara trials
Trials by the same sponsor.
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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 NCT04041492 (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 University of Guadalajara
- Last refreshed: 2 August 2019
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/NCT04041492.
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