NCT04864431

Brief Summary

Several ex vivo, in vitro, and observational studies on various type of cancer shown positive effect of vitamin D. Vitamin D has widely known as immunomodulator property in various diseases. However, it remains limited studies on immunity and cachexia in cancer, particularly in ovarian cancer. This study will investigate the effect of vitamin D in immune response during chemotherapy among epithelial ovarian cancer patients who have a low level of vitamin D and cachexia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

April 11, 2021

Last Update Submit

June 18, 2022

Conditions

Epithelial Ovarian Cancer

Keywords

Vitamin DPre cachexiaCachexiaEpithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8

    lymphocyte CD8 is measured by flowcytometry

    6 months

Secondary Outcomes (6)

  • Find the change of vitamin D level

    6 month

  • Find the daily intake of vitamin D from food

    1 month

  • Find the rate of sun exposure

    1 week

  • Effect of vitamin D in lowering inflammation

    6 months

  • Effect of vitamin D in lowering circulation tumor cells (CTC)

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Vitamin D group

ACTIVE COMPARATOR

Daily vitamin D3 2000 IU on day 1 through day 180 Intervention: vitamin D3 2000 IU

Dietary Supplement: Vitamin D

Control group

PLACEBO COMPARATOR

Daily placebo (saccharum lactis) on day 1 through day 180 Intervention: placebo

Other: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

Vitamin D capsules: each capsule contain 2 tablets of vitamin D 1000 IU. One capsule will be taken on day 1 through 180

Also known as: cholecalciferol
Vitamin D group
PlaceboOTHER

Placebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-60 years old who are newly diagnosed with ovarian cancer based on histopathology
  • epithelial ovarian cancer stage II-III
  • haven't received chemotherapy
  • pre-cachexia or cachexia
  • level of vitamin D below 30 ng/ml
  • no vitamin D allergy
  • ability and willingness to understand and provide informed consent

You may not qualify if:

  • autoimmune disease
  • chronic liver disease
  • chronic renal disease
  • known had hypercalcemia
  • refractory cachexia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 13430, Indonesia

RECRUITING

Tarakan Hospital

Jakarta Pusat, Jakarta Special Capital Region, 13430, Indonesia

NOT YET RECRUITING

Dharmais National Cancer Hospital

Jakarta, 13430, Indonesia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialCachexia

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Nurul Ratna Mutu Manikam, MD, MSc

    Indonesia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurul Ratna Mutu Manikam, MD,MSc

CONTACT

62081210106679nurul.ratna@hotmail.com

Andrijono Andrijono, Prof,MD,PhD

CONTACT

620816844824andrijono@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Neither do investigator nor participants will not know the random allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention group: vitamin D 2000 IU ; Control group: placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 11, 2021

First Posted

April 28, 2021

Study Start

January 12, 2022

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Details will be provided at a later date

Locations

ID(3)