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Effect of Vitamin D Supplementation on Muscle Mass and Function

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ClinicalTrials.gov Identifier: NCT01199926
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Dorothy Teegarden, Purdue University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Obesity
Insulin Resistance
Inflammation
Interventions Dietary Supplement: Vitamin D
Drug: Placebo
Enrollment 34
Recruitment Details Recruitment Start Sept 2008 Recruitment at Purdue University
Pre-assignment Details Following participant recruitment, baseline testing was completed prior to enrollment, study initiation and group assignment.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program. Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Period Title: Overall Study
Started 17 17
Completed 10 13
Not Completed 7 4
Arm/Group Title Vitamin D Placebo Total
Hide Arm/Group Description Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program. Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program. Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
17
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
26  (4.5) 26.2  (5.1) 26.1  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
10
  58.8%
10
  58.8%
20
  58.8%
Male
7
  41.2%
7
  41.2%
14
  41.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 34 participants
17 17 34
1.Primary Outcome
Title Muscle Function
Hide Description The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
Power statistical calculation was completed based on 80% power and error on lean mass measurement.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: kilograms
1.14  (1.22) 1.50  (1.16)
2.Primary Outcome
Title Glucose Tolerance
Hide Description The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention.
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
Power statistical calculation was completed based on 80% power and error on lean mass measurement.
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: mmol/L/120 min
-18.0  (63.4) -25.7  (31.1)
3.Primary Outcome
Title Inflammation
Hide Description The primary endpoint is the change in C reactive protein after the three month intervention
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description:
Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: mg/L
0.64  (1.62) -0.33  (2.60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D Placebo
Hide Arm/Group Description Were asked to consume 4000 IU of vitamin D/day for 3 months while performing a resistance training intervention. Were asked to consume a placebo pill (microcrystalline cellulose) each day for 3 months while performing a resistance training intervention.
All-Cause Mortality
Vitamin D Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Vitamin D Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vitamin D Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dorothy Teegarden
Organization: Purdue University
Phone: 765-494-8791
EMail: teegarden@purdue.edu
Layout table for additonal information
Responsible Party: Dorothy Teegarden, Purdue University
ClinicalTrials.gov Identifier: NCT01199926    
Other Study ID Numbers: GSSI-VitD (0801006402)
First Submitted: September 9, 2010
First Posted: September 13, 2010
Results First Submitted: April 29, 2015
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015