Trial · NCT03078855

A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma

NCT03078855, Phase 3, Completed, Jonathan Friedberg; results first posted 2024-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma. Trials, record NCT03078855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03078855

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
NCT number: NCT03078855
Status: Completed
Phases: Phase 3
Enrollment: 211 participants, actual
Lead sponsor: Jonathan Friedberg
Conditions: Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Mucosal-Associated Lymphoid Tissue Lymphoma
Interventions: Vitamin D, Rituximab, Placebo
First posted: 2017-03-13
Last updated: 2024-09-04
Results first posted: 2024-09-04

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event Free Survival	3 years	Event free survival (EFS) was defined as the time from randomization to lack of response at week 13, initiation of a new treatment, disease progression defined by Lugano criteria, or death, right-censored by time of last follow-up. Per Lugano criteria, progression is defined as a new FDG-avid lesion or an increase in intensity from baseline, an increase by \>= 50% in lesion diameters, a new lymph node \> 1.5 cm in any axis or a new extranodal site \> 1.0 cm.
Secondary	All-Cause Mortality	Participants were followed for survival beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months.	Number of participants who died from any cause between day 1 of treatment and the time of last follow-up.
Secondary	Number of Participants With Treatment Response at 13 Weeks	13 Weeks from the start of treatment	Participants had imaging performed at week 13 to assess response to treatment. A response was defined as partial (PR) or complete response (CR) according to Lugano criteria. Per Lugano criteria for target lesions: PR includes reduced metabolic uptake or a ≥ 50% decrease in the sum of the products of the diameters compared to baseline. CR includes metabolic score of 1, 2 or 3 (out of 5) with or without residual mass or regression of target lesions to ≤ 1.5 cm in the longest dimension.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event Free Survival	3 years	The analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo.	Percentage of Participants	NUMBER
SECONDARY	All-Cause Mortality	Participants were followed for survival beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months.	The analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment Response at 13 Weeks	13 Weeks from the start of treatment	The analysis population included randomized and eligible participants that received at least one dose of vitamin D or placebo and were evaluated for treatment response at 13 weeks.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Event Free Survival	Vitamin D Plus Rituximab	47.7	95% Confidence Interval 39.0 to 58.4	Percentage of Participants
Event Free Survival	Placebo Plus Rituximab	49.5	95% Confidence Interval 37.6 to 65.0	Percentage of Participants
All-Cause Mortality	Vitamin D Plus Rituximab	4		Participants
All-Cause Mortality	Placebo Plus Rituximab	3		Participants
Number of Participants With Treatment Response at 13 Weeks	Vitamin D Plus Rituximab	113		Participants
Number of Participants With Treatment Response at 13 Weeks	Placebo Plus Rituximab	59		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vitamin D Plus Rituximab	139
Overall Study	STARTED	Placebo Plus Rituximab	72
Overall Study	COMPLETED	Vitamin D Plus Rituximab	53
Overall Study	COMPLETED	Placebo Plus Rituximab	32
Overall Study	NOT COMPLETED	Vitamin D Plus Rituximab	86
Overall Study	NOT COMPLETED	Placebo Plus Rituximab	40

Source ClinicalTrials.gov

Adverse events106

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Chills	General disorders	Vitamin D Plus Rituximab	8	135
other	Chills	General disorders	Placebo Plus Rituximab	1	71
other	Fatigue	General disorders	Vitamin D Plus Rituximab	39	135
other	Fatigue	General disorders	Placebo Plus Rituximab	19	71
other	Fever	General disorders	Vitamin D Plus Rituximab	7	135
other	Fever	General disorders	Placebo Plus Rituximab	1	71
other	Infusion related reaction	General disorders	Vitamin D Plus Rituximab	48	135
other	Infusion related reaction	General disorders	Placebo Plus Rituximab	22	71
other	Injection site reaction	General disorders	Vitamin D Plus Rituximab	14	135
other	Injection site reaction	General disorders	Placebo Plus Rituximab	8	71

1 to 10 of 106Source ClinicalTrials.gov

See all 106 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vitamin D Plus Rituximab	4	135
Total, all-cause mortality	Placebo Plus Rituximab	3	71
Total, other adverse events	Vitamin D Plus Rituximab	111	135
Total, other adverse events	Placebo Plus Rituximab	54	71
Total, serious adverse events	Vitamin D Plus Rituximab	16	135
Total, serious adverse events	Placebo Plus Rituximab	9	71

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39677358	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01CA214890	Vitamin D and Follicular Lymphoma	FRIEDBERG, JONATHAN W	UNIVERSITY OF ROCHESTER	NATIONAL CANCER INSTITUTE	2017 to 2022

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vitamin D Plus Rituximab vs Placebo Plus Rituximab: All-Cause Mortality	Trial comparisons
Vitamin D Plus Rituximab vs Placebo Plus Rituximab: Number of Participants With Treatment Response at 13 Weeks	Trial comparisons
Vitamin D Plus Rituximab vs Placebo Plus Rituximab: deaths from any cause	Trial comparisons
Vitamin D Plus Rituximab vs Placebo Plus Rituximab: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03078855

GET https://conductscience.org/api/trials/v1/NCT03078855/events?page=2

API reference For AI assistants