Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

• ClinicalTrials.gov Identifier: NCT02216812
• Recruitment Status: Completed
• First Posted: August 15, 2014
• Results First Posted: September 17, 2018
• Last Update Posted: August 14, 2019
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Neal Chung-Jen Chen, Massachusetts General Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Finger Stiffness; Distal Radius Fracture
• Interventions: Drug: 500 mg vitamin c, 1 pill per day for 6 weeks; Drug: 1 placebo pill for 6 weeks
• Enrollment: 134

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	500 mg Vitamin C	Placebo
Arm/Group Description	Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Period Title: Overall Study
Started	67	67
Completed	57	62
Not Completed	10	5
Reason Not Completed
Lost to Follow-up	10	5

Baseline Characteristics

Arm/Group Title		500 mg Vitamin C	Placebo	Total
Arm/Group Description		Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks	Total of all reporting groups
Overall Number of Baseline Participants		67	67	134
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	67 participants	67 participants	134 participants
		48 (17)	50 (17)	49 (17)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	67 participants	67 participants	134 participants
	Female	47 70.1%	52 77.6%	99 73.9%
	Male	20 29.9%	15 22.4%	35 26.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Non-causcasian	Number Analyzed	67 participants	67 participants	134 participants
		13 19.4%	4 6.0%	17 12.7%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	67 participants	67 participants	134 participants
		67 100.0%	67 100.0%	134 100.0%
Dominant extremity injured [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	67 participants	67 participants	134 participants
		32 47.8%	32 47.8%	64 47.8%
		[1] Measure Description: The number of participants whose injured arm is the same side as that of their dominant hand (i.e., the hand with which they write or perform fine motor skills).
Non-operative treatment; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	67 participants	67 participants	134 participants
		42 62.7%	41 61.2%	83 61.9%
Carpal tunnel release; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	67 participants	67 participants	134 participants
		4 6.0%	9 13.4%	13 9.7%
PROMIS Pain Interference CAT [1]; Mean (Standard Deviation); Unit of measure: T-score
	Number Analyzed	67 participants	67 participants	134 participants
		65 (6.4)	61 (7.1)	63 (7.0)
		[1] Measure Description: The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring the amount pain interferes in the subjects' activities. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T scores above 50 represents more of the measured variable than the average. Investigators measured this at enrollment.

Outcome Measures

1. Primary Outcome

Title	Distance to Palmar Crease Index Through Small Finger
Description	To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.
Time Frame	Day 1 (baseline), 6 weeks

Outcome Measure Data

Analysis Population Description

Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

Arm/Group Title		500 mg Vitamin C	Placebo
Arm/Group Description:		Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Overall Number of Participants Analyzed		67	67
Mean (Standard Deviation); Unit of Measure: Centimeters
Day 1 (baseline)	Number Analyzed	67 participants	67 participants
		6.7 (6.7)	7.1 (6.0)
6 weeks	Number Analyzed	57 participants	62 participants
		2.3 (4.0)	2.0 (3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	500 mg Vitamin C, Placebo
	Comments	We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.63
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	[Not Specified]

2. Secondary Outcome

Title	Active Flexion Index Through Small Finger
Description	Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints
Time Frame	Day 1 (baseline), 6 weeks

Outcome Measure Data

Analysis Population Description

Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

Arm/Group Title		500 mg Vitamin C	Placebo
Arm/Group Description:		Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Overall Number of Participants Analyzed		67	67
Mean (Standard Deviation); Unit of Measure: Degrees
Day 1 (baseline)	Number Analyzed	67 participants	67 participants
		725 (159)	732 (144)
6 weeks	Number Analyzed	57 participants	62 participants
		896 (108)	904 (132)

3. Secondary Outcome

Title	Thumb Motion
Description	Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction
Time Frame	Day 1 (baseline), 6 weeks

Outcome Measure Data

Analysis Population Description

Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

Arm/Group Title		500 mg Vitamin C	Placebo
Arm/Group Description:		Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Overall Number of Participants Analyzed		67	67
Mean (Standard Deviation); Unit of Measure: Degrees
Day 1 (baseline)	Number Analyzed	67 participants	67 participants
		161 (59)	155 (49)
6 weeks	Number Analyzed	57 participants	62 participants
		229 (49)	232 (46)

4. Secondary Outcome

Title	PROMIS Upper Extremity - CAT
Description	The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.
Time Frame	Day 1 (baseline), 6 weeks, 6 months

Outcome Measure Data

Analysis Population Description

Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

Arm/Group Title		500 mg Vitamin C	Placebo
Arm/Group Description:		Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Overall Number of Participants Analyzed		67	67
Mean (Standard Deviation); Unit of Measure: T-score
Day 1 (Baseline)	Number Analyzed	67 participants	67 participants
		26 (7.9)	27 (7.5)
6 weeks	Number Analyzed	57 participants	62 participants
		35 (6.9)	36 (8.4)
6 months	Number Analyzed	48 participants	50 participants
		48 (8.4)	48 (9.1)

5. Secondary Outcome

Title	0-10 Ordinal Pain Score
Description	Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.
Time Frame	Day 1 (baseline), 6 weeks, 6 months

Outcome Measure Data

Analysis Population Description

Some subjects were lost to follow up between time of enrollment and 6 week and 6 month follow up

Arm/Group Title		500 mg Vitamin C	Placebo
Arm/Group Description:		Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Overall Number of Participants Analyzed		67	67
Mean (Standard Deviation); Unit of Measure: units on a scale
Day 1 (baseline)	Number Analyzed	67 participants	67 participants
		3.5 (2.4)	3.8 (2.6)
6 weeks	Number Analyzed	57 participants	67 participants
		1.6 (2.2)	1.8 (1.9)
6 months	Number Analyzed	48 participants	50 participants
		1.4 (2.3)	1.7 (2.2)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	500 mg Vitamin C	Placebo
Arm/Group Description	Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks 500 mg vitamin c, 1 pill per day for 6 weeks	Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
All-Cause Mortality
	500 mg Vitamin C	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/67 (0.00%)	0/67 (0.00%)
Serious Adverse Events
	500 mg Vitamin C	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/67 (0.00%)	0/67 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	500 mg Vitamin C	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/67 (0.00%)	0/67 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Neal Chen
• Organization: Massachusetts General Hospital
• Phone: 617-726-4700
• EMail: nchen1@mgh.harvard.edu

• Responsible Party: Neal Chung-Jen Chen, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02216812
• Other Study ID Numbers: 2014P000561
• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Results First Submitted: June 29, 2018
• Results First Posted: September 17, 2018
• Last Update Posted: August 14, 2019