Trial Outcomes & Findings for Vitamin D Supplementation to Obese Chinese Males (NCT NCT01781169)

NCT ID: NCT01781169

Last Updated: 2013-10-30

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

43 participants

Primary outcome timeframe

Endpoint and baseline of the 8 weeks' trial

Results posted on

2013-10-30

Participant Flow

Subjects were recruited at a medical clinic (Health Service Center of Shuiku Community, Shenzhen, China) in May, 2011.

After enrollment, baseline information of the volunteers including vitamin D nutritional status, health records, etc. were evaluated. Including and excluding criteria were used to select the subjects who were suitable for the intervention trial.

Participant milestones

Participant milestones
Measure	Obese Group Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.	Normal-weight Group Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
Overall Study STARTED	22	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Supplementation to Obese Chinese Males

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal-weight Group n=21 Participants	Obese Group n=21 Participants	Total n=42 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	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	34.4 years STANDARD_DEVIATION 8 • n=5 Participants	44.7 years STANDARD_DEVIATION 8.8 • n=7 Participants	39.5 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment China	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Endpoint and baseline of the 8 weeks' trial

Outcome measures

Outcome measures
Measure	Obese Group n=21 Participants Oral supplementation of vitamin D.	Normal-weight Group n=21 Participants Oral supplementation of vitamin D.
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) Endpoint plasma 25(OH)D level	116.7 nmol/L Standard Deviation 20.3	181.3 nmol/L Standard Deviation 30.2
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) Baseline plasma 25(OH)D level	46.1 nmol/L Standard Deviation 9.1	52.8 nmol/L Standard Deviation 17.8

Adverse Events

Normal-weight Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obese Group

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. Ji-Chang Zhou

Shenzhen Center for Chronic Disease Control

Phone: 86-755-25503842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place