NCT02877277

Brief Summary

This study evaluates whether vitamin C improves responses to epigenetic therapy with DNMTis. Half of the patients will receive vitamin C and DNMTi while the other half will receive placebo and DNMTi.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2017

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

August 9, 2016

Last Update Submit

September 20, 2018

Conditions

Myelodysplastic SyndromeAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (9)

  • Overall 5-hmC/5-mC ratio

    Change from baseline to day 84

  • Overall lysine methylation levels

    Change from baseline to day 84

  • 5-hmC/5-mC ratio at regulatory genomic regions of genes involved in hematopoietic development

    Change from baseline to day 84

  • Accumulation of 5-hmC/5-mC at regulatory regions of ERVs

    Change from baseline to day 84

  • Aberrant histone methylation associated with hematopoietic development

    Change from baseline to day 84

  • Aberrant histone methylation associated with ERVs

    Change from baseline to day 84

  • Expression levels of ERVs

    Change from baseline to day 84

  • Activity of the viral defense pathway measured by RNA and protein expression

    Change from baseline to day 84

  • ERV specific T-cell recognition in vivo

    Change from baseline to day 84

Study Arms (2)

Vitamin C

EXPERIMENTAL

Oral intake of vitamin C tablet (500 mg) daily for 56 days

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Oral intake of placebo tablet daily for 56 days

Dietary Supplement: Placebo

Interventions

Vitamin CDIETARY_SUPPLEMENT

Oral intake of vitamin C tablet (500 mg) daily for 56 days

Vitamin C
PlaceboDIETARY_SUPPLEMENT

Oral intake of placebo tablet daily for 56 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MDS/AML patient in treatment with DNMTi

You may not qualify if:

  • Intake of vitamin C as a dietary supplement including multivitamin
  • Non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

København Ø, 2100, Denmark

Location

Related Publications (1)

  • Gillberg L, Orskov AD, Nasif A, Ohtani H, Madaj Z, Hansen JW, Rapin N, Mogensen JB, Liu M, Dufva IH, Lykkesfeldt J, Hajkova P, Jones PA, Gronbaek K. Oral vitamin C supplementation to patients with myeloid cancer on azacitidine treatment: Normalization of plasma vitamin C induces epigenetic changes. Clin Epigenetics. 2019 Oct 17;11(1):143. doi: 10.1186/s13148-019-0739-5.

    PMID: 31623675DERIVED

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Kirsten Grønbæk, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 24, 2016

Study Start

August 8, 2016

Primary Completion

May 29, 2017

Study Completion

May 29, 2017

Last Updated

September 24, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)