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NCT02786823
Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes
Phase 2, PHASE3 trial testing Folic acid in Diabetes Mellitus, Type 2 in 80 participants. Completed in 15 September 2017.
15 August 2017
Quick facts
| Lead sponsor | All India Institute of Medical Sciences, Bhubaneswar |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 May 2017 |
| Primary completion | 15 August 2017 |
| Estimated completion | 15 September 2017 |
| Sites | 1 location across India |
Drugs / interventions tested
- Folic acid (FOLIC ACID) — full drug profile →
- Vitamin B12 — full drug profile →
- Oral hypoglycemic agents [Metformin +/- Sulfonylurea] — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Who can join
Adults 30 to 65, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the effect of Folic acid and Vitamin B12 supplementation on Biochemical parameters in subjects with type-2 Diabetes. 80 selected subjects will be divided into 4 groups of 20 each. * Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral anti-diabetic drugs; * Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs; * Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs; * Group D: to receive no additional intervention apart from standard oral anti-diabetic drugs. The biochemical parameters will be evaluated before and after the intervention.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Folic acid and vitamin B12 supplementation in subjects with type 2 diabetes mellitus: A multi-arm randomized controlled clinical trial.
Satapathy S, Bandyopadhyay D, Patro BK, Khan S, et al · · 2020 · cited 29× · PMID 33066869 · DOI 10.1016/j.ctim.2020.102526
Verify or expand the search:
- PubMed search for NCT02786823
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other All India Institute of Medical Sciences, Bhubaneswar 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 NCT02786823 (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 All India Institute of Medical Sciences, Bhubaneswar
- Last refreshed: 19 September 2017
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/NCT02786823.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing