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Trial Outcomes & Findings for Assess Vitamin D Levels in Those With & Without Thyroid Cancer (NCT NCT00719615)

NCT ID: NCT00719615

Last Updated: 2023-10-16

Results Overview

We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, \& 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D \< 30 ng/ml.

Recruitment status

COMPLETED

Target enrollment

111 participants

Primary outcome timeframe

Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database

Results posted on

2023-10-16

Participant Flow

Individuals (at University of Nebraska Medical Center)were selected from a thyroid tumor and cancer collaborative registry (TCCR), database \& biospecimen bank, started March 2008. We achieved a sample size of 111 subjects with 24 patients with active thyroid cancer, 45 patients with thyroid cancer in remission and 42 patients with thyroid nodules.

Individuals who had agreed to participate in the TCCR and who had also given a blood sample were included in sequential order.

Participant milestones

Participant milestones
Measure
Thyroid Nodules
Thyroid Cancer in Remission
Active Thyroid Cancer
Overall Study
STARTED
42
45
24
Overall Study
COMPLETED
42
45
24
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assess Vitamin D Levels in Those With & Without Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Thyroid Nodules
n=42 Participants
Thyroid Cancer in Remission
n=45 Participants
Active Thyroid Cancer
n=24 Participants
Total
n=111 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
40 Participants
n=99 Participants
44 Participants
n=107 Participants
22 Participants
n=206 Participants
106 Participants
n=7 Participants
Age, Categorical
>=65 years
2 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
5 Participants
n=7 Participants
Sex: Female, Male
Female
38 Participants
n=99 Participants
39 Participants
n=107 Participants
17 Participants
n=206 Participants
94 Participants
n=7 Participants
Sex: Female, Male
Male
4 Participants
n=99 Participants
6 Participants
n=107 Participants
7 Participants
n=206 Participants
17 Participants
n=7 Participants
Region of Enrollment
United States
42 participants
n=99 Participants
45 participants
n=107 Participants
24 participants
n=206 Participants
111 participants
n=7 Participants

PRIMARY outcome

Timeframe: Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database

Population: This study is a pilot study to provide preliminary data. Per protocol, we accrued 37% of the sample size needed for a fully powered study. Using the outcome "the proportion of persons with "vitamin D deficiency", a sample size of 160 subjects (64 nodule, 64 remission, and 32 active) would achieve an 80% power to detect an effect size of 0.25.

We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, \& 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D \< 30 ng/ml.

Outcome measures

Outcome measures
Measure
Thyroid Nodules
n=42 Participants
Thyroid Cancer in Remission
n=45 Participants
Active Thyroid Cancer
n=24 Participants
Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups.
23 participants
20 participants
11 participants

Adverse Events

Thyroid Nodules

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Thyroid Cancer in Remission

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Thyroid Cancer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Whitney S Goldner, MD

University of Nebraska Medical Center

Phone: 402-559-6205

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place