Trial Outcomes & Findings for Magnesium is Associated With QoL in COPD: A Cross-sectional Study (NCT NCT01564953)

Results Overview

vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L

Recruitment status

COMPLETED

Target enrollment

143 participants

Primary outcome timeframe

one year

Results posted on

2017-03-06

Participant Flow

Recruitment took place in an outpatient clinic for respiratory diseases in Aarhus University Hospital, Denmark, during summertime in order to minimize seasonal variations of serum vitamin D.

Missed inclusion was due to either unstable disease (54 patients) or unwillingness to participate (87 patients).

Participant milestones

Participant milestones
Measure	Serum Vitamin D, Magnesium and Calcium Deficient Groups Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
Overall Study STARTED	143
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnesium is Associated With QoL in COPD: A Cross-sectional Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Serum Vitamin D, Magnesium and Calcium Deficient Groups n=143 Participants Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	99 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants
Gender Female	66 Participants n=5 Participants
Gender Male	77 Participants n=5 Participants
Region of Enrollment Denmark	143 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L

Outcome measures

Outcome measures
Measure	Serum Vitamin D n=143 Participants Participants' serum vitamin D
Serum Vitamin D	75.13 mmol/L Standard Deviation 33.62

SECONDARY outcome

Timeframe: one year

Forced expiratory ventilation in 1 second, in percent of predicted

Outcome measures

Outcome measures
Measure	Serum Vitamin D n=143 Participants Participants' serum vitamin D
Lung Function Test	52 percentage of predicted Interval 33.0 to 71.0

SECONDARY outcome

Timeframe: One year

Serum magnesium in plasma, in mmol/L

Outcome measures

Outcome measures
Measure	Serum Vitamin D n=143 Participants Participants' serum vitamin D
Serum Magnesium	0.82 mmol/L Standard Deviation 0.08

SECONDARY outcome

Timeframe: One year

Serum ionized calcium, in mmol/L

Outcome measures

Outcome measures
Measure	Serum Vitamin D n=143 Participants Participants' serum vitamin D
Serum Calcium	1.23 mmol/L Standard Deviation 0.04

SECONDARY outcome

Timeframe: One year

Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test. Minimum score was 0 (no symptoms) and maximum score was 40 (many symptoms).

Outcome measures

Outcome measures
Measure	Serum Vitamin D n=143 Participants Participants' serum vitamin D
Quality of Life	24 units on a scale Interval 22.0 to 28.0

Adverse Events

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. Sarah Hashim Ali Hussein

Aarhus University Hospital

Phone: 0045 42660308

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place