Trial Outcomes & Findings for Effect of Vitamin D Supplementation on Muscle Mass and Function (NCT NCT01199926)

Results Overview

The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

three months

Results posted on

2015-05-15

Participant Flow

Recruitment Start Sept 2008 Recruitment at Purdue University

Following participant recruitment, baseline testing was completed prior to enrollment, study initiation and group assignment.

Participant milestones

Participant milestones
Measure	Vitamin D Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.	Placebo Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Overall Study STARTED	17	17
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Vitamin D Supplementation on Muscle Mass and Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D n=17 Participants Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.	Placebo n=17 Participants Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26 years STANDARD_DEVIATION 4.5 • n=5 Participants	26.2 years STANDARD_DEVIATION 5.1 • n=7 Participants	26.1 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: three months

Population: Power statistical calculation was completed based on 80% power and error on lean mass measurement.

The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.

Outcome measures

Outcome measures
Measure	Vitamin D n=10 Participants Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.	Placebo n=13 Participants Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Muscle Function	1.14 kilograms Standard Deviation 1.22	1.50 kilograms Standard Deviation 1.16

PRIMARY outcome

Timeframe: three months

Population: Power statistical calculation was completed based on 80% power and error on lean mass measurement.

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.

Outcome measures

Outcome measures
Measure	Vitamin D n=10 Participants Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.	Placebo n=13 Participants Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Glucose Tolerance	-18.0 mmol/L/120 min Standard Deviation 63.4	-25.7 mmol/L/120 min Standard Deviation 31.1

PRIMARY outcome

Timeframe: three months

The primary endpoint is the change in C reactive protein after the three month intervention

Outcome measures

Outcome measures
Measure	Vitamin D n=10 Participants Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.	Placebo n=13 Participants Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Inflammation	0.64 mg/L Standard Deviation 1.62	-0.33 mg/L Standard Deviation 2.60

Adverse Events

Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Dorothy Teegarden

Purdue University

Phone: 765-494-8791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place