Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05650437 |
| Other study ID # |
66 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2022 |
| Est. completion date |
December 15, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
70 postmenopausal women, aged 50 to 60, who are vitamin D deficient and diagnosed with
osteoporosis or osteopenia with T score of DEXA of lumbar spine (L1 to L4) was less than or
equal -1 and their body mass index between 25 and 30 kg/m2. They will be divided into two
groups by randomization. 35 postmenopausal women in Group (A) will undergo three weekly
sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800
IU) daily for three months. For three months, group (B), which consists of 35 postmenopausal
women, will undergo daily aerobic exercise and vitamin D supplementation (800 IU) only.
The amount of serum 25-hydroxyvitamin D was measured using ELISA kits, bone mineral density
of lumber spine was measured by dual energy X-ray absorptiometry (DEXA), and the torque of
knee flexors and extensors was evaluated using the Biodex System 3 isokinetic dynamometer,
Description:
Group (A): This group covers a sum of 35 postmenopausal women who underwent three weekly
sessions of UV light therapy in addition to daily vitamin D supplements of 800 IU.
Ultraviolet therapy device It was an ultraviolet arc lamp made of a low-pressure mercury
discharge tube with an internal phosphor coating. The chemical makeup of the phosphor
utilized determined the specific wavelength and output of each light (mixtures of phosphates,
borates, and silicates). This produces a sizable amount of UVA and UVB but none of UVC. The
spectrum of the radiation: is 280-320 nm. Postmenopausal women in the group received
treatment with quartz of the type 4004/2n- Verret (A).
Using dose-response assessment, which is graded according to the individual's erythema
response and is classified as E1, Second-degree erythema (E2), Third-degree erythema (E3),
and Fourth-degree erythema, the physical therapist determined the postmenopausal woman's
sensitivity to UV before applying UV (E4).
The physical therapist instructed each case to wear safety glasses (goggles) to protect her
eyes from UV, and treatment duration was calculated as a percentage of the MED of UV. The
woman was then instructed to take off all of her clothes and wash her abdomen. After
describing the steps to the woman and requesting that she avoid looking at the bulb due to
the risk of eye damage. The therapist cut three holes, each measuring 2 by 2 cm, into a piece
of cardboard that was about 4 by 20 cm in size.
Subsequently, the region around the cardboard was covered with a cloth to prevent the skin
nearby from being exposed to radiation by placing the cardboard on the abdomen. The lamp was
turned on and positioned 70 cm away and perpendicular to the abdominal region. Before turning
toward the woman, the arc lamp needed five to ten minutes to warm up and attain maximum
power. The UV beam was pointed straight at the abdomen region after the lamp had achieved
maximum power, which activated the timer. The three holes were exposed to UV light for 30
seconds at a time, after which two holes were covered and one was left unattended for the
following 30 seconds.
The first hole was exposed for 90 seconds, the second for 60 seconds, and the third for 30
seconds by this protocol. Then, instruct the woman to document the region's reaction for 24
hours after exposure. The area that experienced minor skin reddening within eight hours and
faded within twenty-four hours was given MED treatment. The minimum erythemal dose (MED) or
E1 was the desired dose in this study.
Following the determination of the MED for each woman, the UV session was conducted as
follows: To maximize exposure of the portion being treated and prevent unnecessary exposure
of other parts, the postmenopausal lady was directed to remove clothing from the lower
abdomen and lie in a supine position.
As for the rest of the body, which did not require exposure, it was covered. Goggles are
necessary to shield the eyes from exposure. After that, the ultraviolet Arc lamp was adjusted
so that it is positioned approximately 70 cm above the lower abdominal region in a
perpendicular position. By the MED for each lady that was spotted, the lamp was switched on
and the timer was changed.
The lamp was turned off and moved away from the postmenopausal woman by the end of the
therapy period. Any noticeable reaction to the therapy was recorded within the three
treatment sessions per week which were administered for a total of three months.
Aerobic exercise The postmenopausal women in groups (A and B) exercised on the treadmill;
women should always warm up before beginning exercise and stop if they experience pain or
shortness of breath. Each session lasted 30 minutes and included 5 minutes of warming up and
20 minutes of walking at 60% of their maximum heart rate (MHR). The maximum heart rate that
the circulatory system can support during physical exercise is MHR=220. Three sessions a week
for three months, followed by a five-minute cool-down [10].
Vitamin D supplementation Throughout three months, vitamin D supplements (800 IU) were given
to all postmenopausal women in both groups (A&B).
The Group (B): This group comprises of 17 postmenopausal women who completed 3 months of
daily aerobic exercise and vitamin D supplementation (800 IU).
