Trial Outcomes & Findings for Topical Delivery of Vitamin D3 as Vitamin D Supplementation (NCT NCT02735200)

NCT ID: NCT02735200

Last Updated: 2017-06-14

Results Overview

Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 550 participants
• Primary outcome timeframe: baseline and 5 months
• Results posted on: 2017-06-14

Participant Flow

Orthopedic clinics

consecutive patients

Participant milestones

Measure	Application of Aloe Vera Gel Intervention: aloe vera gel administration was applied 1 gram daily for 120 days.	Topical Application of Vitamin D3 topical vitamin D3 in intervention group: local application of Top-D, 1 gram (5000 IU) was applied every day, for 120 days.
Overall Study STARTED	200	350
Overall Study COMPLETED	192	345
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Measure	Application of Aloe Vera Gel Intervention: aloe vera gel administration was applied 1 gram daily for 120 days.	Topical Application of Vitamin D3 topical vitamin D3 in intervention group: local application of Top-D, 1 gram (5000 IU) was applied every day, for 120 days.
Overall Study Lost to Follow-up	0	5
Overall Study Withdrawal by Subject	8	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Topical Application of Vitamin D3 n=350 Participants this arm received topical vitamin D3 1gram (5000IU)	Application of Aloe Vera Gel n=200 Participants Intervention: aloe vera gel administration 1 gram	Total n=550 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=350 Participants	0 Participants n=200 Participants	0 Participants n=550 Participants
Age, Categorical Between 18 and 65 years	300 Participants n=350 Participants	171 Participants n=200 Participants	471 Participants n=550 Participants
Age, Categorical >=65 years	50 Participants n=350 Participants	29 Participants n=200 Participants	79 Participants n=550 Participants
Age, Continuous	42.59 years STANDARD_DEVIATION 15.74 • n=350 Participants	41.6 years STANDARD_DEVIATION 16.6 • n=200 Participants	41.9 years STANDARD_DEVIATION 16.1 • n=550 Participants
Sex: Female, Male Female	285 Participants n=350 Participants	137 Participants n=200 Participants	422 Participants n=550 Participants
Sex: Female, Male Male	65 Participants n=350 Participants	63 Participants n=200 Participants	128 Participants n=550 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Saudi Arabia	350 participants n=350 Participants	200 participants n=200 Participants	550 participants n=550 Participants

PRIMARY outcome

Timeframe: baseline and 5 months

Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.

Outcome measures

Measure	Topical Application of Vitamin D3 n=345 Participants Intervention: patients will be administered topical vitamin D3 5000 IU topical vitamin D3 in intervention group: local application	Application of Aloe Vera Gel n=192 Participants Intervention: aloe vera gel administration
Level of Serum 25 OHD Level Pre-treatment and Post Treatment post treatment	37.17 ng/mL Standard Deviation 6.04	10.51 ng/mL Standard Deviation 3.5
Level of Serum 25 OHD Level Pre-treatment and Post Treatment pre treatment	12.03 ng/mL Standard Deviation 4.57	10.36 ng/mL Standard Deviation 4.09

Adverse Events

Topical Application of Vitamin D3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Application of Aloe Vera Gel

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 Dalal Bubshait

Dammam University

Phone: +966505848281

Email: dbubshait@ud.edu.sa

Results disclosure agreements

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