Trial Outcomes & Findings for Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women (NCT NCT01344161)

Results Overview

Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

85 participants

Primary outcome timeframe

3 months minus baseline

Results posted on

2012-10-11

Participant Flow

In November 2009 we distributed advertisements in campus of Tehran University of Medical Sciences (TUMS) and invited all female students and employee to participate in our study.

Participant milestones

Participant milestones
Measure	Lactose In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.	Vitamin D In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
Overall Study STARTED	43	42
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactose In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.	Vitamin D In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
Overall Study Lost to Follow-up	4	1
Overall Study Pregnancy	0	1
Overall Study Protocol Violation	1	1

Baseline Characteristics

Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactose n=38 Participants In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.	Vitamin D n=39 Participants In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.	Total n=77 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	38 Participants n=5 Participants	39 Participants n=7 Participants	77 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	38.9 years STANDARD_DEVIATION 7 • n=5 Participants	37 years STANDARD_DEVIATION 8 • n=7 Participants	38 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	38 participants n=5 Participants	39 participants n=7 Participants	77 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months minus baseline

Population: We assessed body composition by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).

Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.

Outcome measures

Outcome measures
Measure	Vitamin D n=39 Participants 25 microgram cholecalciferol	Placebo n=38 Participants 25 microgram lactose
Change in Body Fat Mass	-2.7 kg Standard Deviation 2	-0.4 kg Standard Deviation 2

PRIMARY outcome

Timeframe: 3 months minus baseline

Outcome measures

Outcome measures
Measure	Vitamin D n=39 Participants 25 microgram cholecalciferol	Placebo n=38 Participants 25 microgram lactose
Change in Glucose Concentrations	-0.28 mmol/L Standard Deviation 0.4	-0.65 mmol/L Standard Deviation .4

PRIMARY outcome

Timeframe: 3 months minus baseline

It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).

Outcome measures

Outcome measures
Measure	Vitamin D n=39 Participants 25 microgram cholecalciferol	Placebo n=38 Participants 25 microgram lactose
Change in Post Load Glucose Concentrations	-0.29 mmol/L Standard Deviation 0.9	-0.3 mmol/L Standard Deviation 1.1

PRIMARY outcome

Timeframe: 3 months minus baseline

Outcome measures

Outcome measures
Measure	Vitamin D n=39 Participants 25 microgram cholecalciferol	Placebo n=38 Participants 25 microgram lactose
Change in Insulin Concentrations	-24.8 pmol/L Standard Deviation 20.2	-19 pmol/L Standard Deviation 23.3

Adverse Events

Lactose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D

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.Farzad Shidfar

Tehran University of Medical Sciences

Phone: 09123082922

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place