ClinicalTrials.gg
CompletedNCT03504280Updated Apr 20, 2018

Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol

An interventional study of Cholecalciferol in Hypovitaminosis D, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed. Open to participants aged 21 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Apr 2015, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
21 Years to 39 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 228 studies testing cholecalciferol in Vitamin D Deficiency — 9 open to participants now, 16 under way, 2 of them phase 3. Cholecalciferol · Vitamin D Deficiency.

Enrollment
85th of 228
105 · median 72
Started
2015
with 19 others
No phase
113 of 228
6 open now
Registered
166th of 228
by date

Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, this one is the 85th largest by enrollment, is one of 20 that started in 2015, is one of 113 with no phase, and was the 166th registered.

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

Browse Vitamin D Deficiency studies →

Open to participants now

9 of the 228 studies testing cholecalciferol in Vitamin D Deficiency are open now, in 7 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

About cholecalciferol

Cholecalciferol: first FDA approval 2000 (INFUVITE ADULT), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.

This study: 21 Years to 39 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 228 studies testing cholecalciferol in Vitamin D Deficiency, or all of them as a file.
02

Study summary

it is a clinical trial to observe increase in serum vitamin D level and clinical symptoms after 3 different doses of cholecalciferol given either intramuscularly or oral.

Read the detailed description

A prospective, interventional study was conducted in Department of Rheumatology, BSMMU, Dhaka, Bangladesh from October 2015 to January 2017. One hundred and five clinically healthy adults of age 21-39 with serum vitamin D concentration were enrolled in the study. Serum vitamin D level was estimated by chemiluminescent micro particle immunoassay method at baseline and 3 months after the intervention. The participants were divided into three groups using random number table. Group A was given 6 lakh IU of cholecalciferol IM stat dose, group B was given 6 lakh IU of cholecalciferol orally with a glass of milk stat dose and group c was given 2 lakh IU of cholecalciferol orally once a month for 2 months followed by tablet cholecalciferol 1000 IU daily.

03

Conditions studied

  • Hypovitaminosis D

Browse trials for

Keywords

  • hypovitaminosis D
  • cholecalciferol
  • mehadose
04

Who can participate

Ages eligible
21 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hypovitaminosis D (serum 25 OH D \< 20 ng/ml)

Exclusion criteria

Exclusion Criteria:

  • Chronic disease causing Vitamin D deficiency like CKD, nephrotic syndrome, liver disease, hyperparathyroidism, history of skin graft, malabsorption, hyperthyroidism, drugs like anticonvulsants, , HAART Current pregnancy Lactose intolerance Previously treated with bolus Vitamin D supplementation within previous three months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Active comparator
    high dose IM

    cholecalciferol 600,000 IU given intramuscularly

    Drug: Cholecalciferol

  • Active comparator
    high dose oral

    cholecalciferol 600,000 IU given orally

    Drug: Cholecalciferol

  • Active comparator
    low dose oral

    cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU

    Drug: Cholecalciferol

Interventions

06

What researchers measure

Primary outcomes

  1. serum 25(OH)D

    serum vitamin D level in ng/ml measured by CLIA method

    Time frame: 3 months

Secondary outcomes

  1. fatigue

    visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale

    Time frame: 3 months

  2. generalized weakness

    visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale

    Time frame: 3 months

  3. bone pain

    visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale

    Time frame: 3 months

  4. muscle cramps

    visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale

    Time frame: 3 months

  5. pain in weight bearing joints

    visual analog scale of pain in weight bearing joints during last 7 days of interview measured in 10 cm scale

    Time frame: 3 months

  6. difficulty in climbing stairs

    visual analog scale of difficulty in climbing stairs during last 7 days of interview measured in 10 cm scale

    Time frame: 3 months

  7. difficulty in standing from squatting position

    visual analog scale of difficulty in standing from squatting position during last 7 days of interview measured in 10 cm scale

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2015 to primary completion in Aug 2017, 28 months.

Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 28 months is above that.

Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2018
First posted
Apr 20, 2018
StartActual
Apr 2015
Primary completionActual
Aug 2017
CompletionActual
Oct 2017
Last update
Apr 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03504280
Responsible party
Dr Shweta Nakarmi (Principle Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh) — Principal investigator
First posted
Apr 20, 2018
Start date
Apr 2015
Primary completion
Aug 2017
Completion
Oct 2017
Last update
Apr 20, 2018

Study contacts

Shweta Nakarmi, resident
principal investigator · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Md Nazrul Islam, professor
study director · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Cholecalciferol

Start the discussion