Vitamin D Deficiency
Conditions
Brief summary
After obtaining the approval from the IRB of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.
Detailed description
After obtaining the approval from the Institutional Review Board (IRB) of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) I gram gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.
Interventions
DRUGApplication of topical vitamin d3 (Top-D)
Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days
OTHERApplication of Aloe vera gel
aloe vera gel will be applied Dosage: 1 gram Duration: 120 days Frequency: Daily
Sponsors
Imam Abdulrahman Bin Faisal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
all men and women with vitamin D insufficiency and deficiency Must be able to apple the topical vitamin D3 Must be willing to sign and informed consent
Exclusion criteria
* Those who have normal 25OHD levels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Serum 25 OHD Level Pre-treatment and Post Treatment | 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. |
Countries
Saudi Arabia
Participant flow
Recruitment details
Orthopedic clinics
Pre-assignment details
consecutive patients
Participants by arm
| Arm | Count |
|---|---|
| Topical Application of Vitamin D3 this arm received topical vitamin D3 1gram (5000IU) | 350 |
| Application of Aloe Vera Gel Intervention: aloe vera gel administration 1 gram | 200 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 5 |
| Overall Study | Withdrawal by Subject | 8 | 0 |
Baseline characteristics
| Characteristic | Application of Aloe Vera Gel | Total | Topical Application of Vitamin D3 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 79 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 171 Participants | 471 Participants | 300 Participants |
| Age, Continuous | 41.6 years STANDARD_DEVIATION 16.6 | 41.9 years STANDARD_DEVIATION 16.1 | 42.59 years STANDARD_DEVIATION 15.74 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Saudi Arabia | 200 participants | 550 participants | 350 participants |
| Sex: Female, Male Female | 137 Participants | 422 Participants | 285 Participants |
| Sex: Female, Male Male | 63 Participants | 128 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 345 | 0 / 192 |
| other Total, other adverse events | 0 / 345 | 0 / 192 |
| serious Total, serious adverse events | 0 / 345 | 0 / 192 |
Outcome results
Primary
Level of Serum 25 OHD Level Pre-treatment and Post Treatment
Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.
Time frame: baseline and 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topical Application of Vitamin D3 | Level of Serum 25 OHD Level Pre-treatment and Post Treatment | pre treatment | 12.03 ng/mL | Standard Deviation 4.57 |
| Topical Application of Vitamin D3 | Level of Serum 25 OHD Level Pre-treatment and Post Treatment | post treatment | 37.17 ng/mL | Standard Deviation 6.04 |
| Application of Aloe Vera Gel | Level of Serum 25 OHD Level Pre-treatment and Post Treatment | pre treatment | 10.36 ng/mL | Standard Deviation 4.09 |
| Application of Aloe Vera Gel | Level of Serum 25 OHD Level Pre-treatment and Post Treatment | post treatment | 10.51 ng/mL | Standard Deviation 3.5 |
p-value: 0.9t-test, 2 sided
p-value: <0.001t-test, 2 sided