Trial Outcomes & Findings for Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients (NCT NCT01385098)

NCT ID: NCT01385098

Last Updated: 2018-01-23

Results Overview

Serum 25(OH)D ng/ml levels at baseline and 12 weeks following bariatric surgery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2018-01-23

Participant Flow

Participant milestones

Measure	Vitamin D3 and Calcium Dietary supplement of vitamin D3 and calcium Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day
Overall Study STARTED	37
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Vitamin D3 and Calcium Dietary supplement of vitamin D3 and calcium Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day
Overall Study Adverse Event	10
Overall Study Lost to Follow-up	4

Baseline Characteristics

Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients

Baseline characteristics by cohort

Measure	Vitamin D3 and Calcium n=23 Participants Dietary supplement of vitamin D3 and calcium Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day
Age, Continuous	41 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
BMI, kg/m^2	46.3 kg/m^2 STANDARD_DEVIATION 8.1 • n=5 Participants
Body weight, lb	278 lb STANDARD_DEVIATION 52 • n=5 Participants
Excess body weight, lb	128 lb STANDARD_DEVIATION 47 • n=5 Participants
Surgery type Sleeve Gastrectomy	11 Participants n=5 Participants
Surgery type Roux-Y Gastric Bypass	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Serum 25(OH)D ng/ml levels at baseline and 12 weeks following bariatric surgery

Outcome measures

Measure	Vitamin D3 and Calcium n=23 Participants Dietary supplement of vitamin D3 and calcium Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day	Roux-Y Gastric Bypass Dietary supplement of vitamin D3 and calcium Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day
Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation Preoperative	19.1 ng/mL Standard Deviation 9.0	—
Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation 12 weeks	27.2 ng/mL Standard Deviation 8.4	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

We anticipate that vitamin D supplementation of Roux-en Y bariatric surgery patients will be less effective in improving or maintaining vitamin D status.

Outcome measures

Measure	Vitamin D3 and Calcium n=11 Participants Dietary supplement of vitamin D3 and calcium Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day	Roux-Y Gastric Bypass n=12 Participants Dietary supplement of vitamin D3 and calcium Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day
Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy Preoperative	18.5 ng/mL Standard Deviation 9.6	19.6 ng/mL Standard Deviation 8.3
Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy 12 Weeks	26.3 ng/mL Standard Deviation 9.6	28.1 ng/mL Standard Deviation 7.6

Adverse Events

Vitamin D3 and Calcium

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

Sherman Vadim

Houston Methodist Hosptial

Phone: 713-441-5514

Email: vsherman@tmhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place