Vitamin D DeficiencyPhase 4NCT04183257
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
A Phase 4 study testing oral vitamin D in people with Vitamin D Deficiency and Insulin Resistance, run by King Edward Medical University.
Trial summary
In addition to its effect on maintaining calcium homeostasis and mineralization of bone, vitamin D has been linked to play a pivotal role in different medical conditions including type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Vitamin D Deficiency, Insulin Resistance, Diabetes Mellitus, Type 2
- What is being tested?
- oral vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2016to 30 Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age 25 to 50 years as type 2 diabetes usually diagnosed in this age range.
- Patients having Type 2 Diabetes Mellitus
- Taking oral antidiabetic medicines
- Serum 25(OH) vitamin D levels below 20ng/ml having no clinical symptoms of vitamin D deficiency.
- HOMA-IR > 2.5
Who cannot join
- Patients having evidence of liver dysfunction and chronic renal insufficiency because it will alter the metabolism of cholecalciferol.
- Patients having parathyroid dysfunction diagnosed on the basis of blood tests as replacement of vitamin D in these patients is very complex.
- Patients having gastrointestinal surgeries that will alter the absorption of cholecalciferol diagnosed from detailed clinical history and clinical examination.
- Patients having clinical features of gastroparesis diagnosed on the basis of clinical history as it can alter the absorption of vitamin D.
- Patients having erratic control of diabetes requiring multiple hospital admissions for diabetic emergencies.
- Pregnant and lactating mothers.
- -
About this study
In addition to its effect on maintaining calcium homeostasis and mineralization of bone, vitamin D has been linked to play a pivotal role in different medical conditions including type 2 diabetes mellitus. Vitamin D plays a major role in both insulin secretion and decreasing the insulin resistance hence has a major impact on glucose tolerance. This study is designed to determine the non-skeletal effects of vitamin D in improving the glucose tolerance in type 2 diabetic patients by decreasing the insulin resistance
Read the detailed description
Pakistan stands at seventh spot amongst the world having patients suffering from Type 2 Diabetes Mellitus (T2DM) with the prevalence of approximately 6.9 million in 2007.
Among the risk factors for the development of T2DM, there is a growing evidence that deficiency of vitamin D is an independent risk factor for its development and poor glycemic control. Vitamin D plays a significant role not only in secretion of insulin from the beta cells of pancreas but it also helps in decreasing the insulin resistance at the level of target cells.
Vitamin D has received an enormous attention recently. A report from Australia indicated 1 in 3 Australians are Vitamin D deficient. Reports from Pakistan have also demonstrated Vitamin D deficiency. The study conducted by Haroon Khan et al had 562 (76.2%) females while 175 (23.8%) were males. Mean age of respondents was 36.3 years (age range 15-75 years. Females had significantly lower mean Vitamin D levels (56.2%) compared to males (15.3%).
25(OH) Vitamin D is the circulating form of vitamin D which is measurable in the blood. Vitamin D insufficiency has been defined as serum 25-hydroxyvitamin D (25(OH) D) levels below 30 ng/mL and it is common among patients with T2DM. Many studies have revealed that Vitamin D3 (calcitriol) has a role in the synthesis and the secretion of insulin by receptor mediated molecular mechanisms.
Moreover Vitamin D functions are not limited to skeletal health benefits and may extend to preservation of insulin secretion and insulin sensitivity. Studies have revealed the association between vitamin D deficiency and changes in blood glucose and insulin levels as well as sensitivity of the target tissues to insulin .Cross-sectional data provide some evidence that circulating 25-hydroxyvitamin D (25(OH) D) is inversely associated with insulin resistance, although direct measurements of insulin sensitivity are required for confirmation. Available prospective studies support a protective influence of high 25(OH) D concentrations on type 2 diabetes mellitus risk. Vitamin D receptor gene polymorphisms and vitamin D interactions with the insulin like growth factor system may further influence glucose homeostasis. The ambiguity of optimal vitamin D dosing regimens and optimal therapeutic concentrations of serum 25(OH) D limit available intervention studies.
A study found no improvement in glucose tolerance following the administration of two vitamin D doses with an interval of 2 weeks to thirty-seven non-diabetic, vitamin D-deficient adults.
Another study reported a randomised, controlled trial of vitamin D3, three fortnightly doses of 120 000 IU or placebo, in centrally obese Indian men. The subjects were not necessarily insulin resistant, but there was some improvement in postprandial insulin sensitivity following supplementation. A recent systematic review and meta-analysis on the role of vitamin D and calcium in type 2 diabetes conclude that 'there appears to be a relationship' but due to the paucity of data, an understanding of the mechanisms is incomplete.
This study has a novelty in the dosage and the frequency of administration of vitamin D which has not been studied yet. This study will enable to determine the impact of vitamin D replacement on insulin resistance in vitamin D deficient Type 2 diabetic patients and to find any correlation of serum levels of 25 hydroxyvitamin D levels with the degree of insulin resistance.
- Being tested
- oral vitamin D
- Keywords
- Vitamin D, T2DM, Insulin Resistance
- Medical subject headings
- Vitamin D Deficiency, Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral vitamin DDrug
Also called oral vitamin D 400IU
oral Vitamin D 400IU will be given and will be escalated every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Experimental | vitamin D arm will receive oral vitamin D in escalating dosage. Receives: Drug: oral vitamin D |
| Conventional | No intervention | This arm will receive conventional treatment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostatic Model Assessment of Insulin Resistance
insulin resistance reduction to <2.5
Measured: 3 months
Secondary outcomes (1)
Glycated Hemoglobin (HbA1C)
Reduction by 0.5%
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start30 Sep 2016
- Primary completion30 Apr 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawad Ahmad Randhawa, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183257
- Sponsor's protocol ID
- to be ascertained
- Status last verified
- Dec 2019
- First submitted
- 7 Sep 2015
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT04183257
- Acronym / sponsor ID
- to be ascertained
- Keywords
- Vitamin D, T2DM, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In addition to its effect on maintaining calcium homeostasis and mineralization of bone, vitamin D has been linked to play a pivotal role in different medical conditions including type 2 diabetes mellitus. Vitamin D plays a major role in both insulin secretion and decreasing the insulin resistance hence has a major impact on glucose tolerance. This study is designed to determine the non-skeletal effects of vitamin D in improving the glucose tolerance in type 2 diabetic patients by decreasing the insulin resistance
Detailed description
Pakistan stands at seventh spot amongst the world having patients suffering from Type 2 Diabetes Mellitus (T2DM) with the prevalence of approximately 6.9 million in 2007.
Among the risk factors for the development of T2DM, there is a growing evidence that deficiency of vitamin D is an independent risk factor for its development and poor glycemic control. Vitamin D plays a significant role not only in secretion of insulin from the beta cells of pancreas but it also helps in decreasing the insulin resistance at the level of target cells.
Vitamin D has received an enormous attention recently. A report from Australia indicated 1 in 3 Australians are Vitamin D deficient. Reports from Pakistan have also demonstrated Vitamin D deficiency. The study conducted by Haroon Khan et al had 562 (76.2%) females while 175 (23.8%) were males. Mean age of respondents was 36.3 years (age range 15-75 years. Females had significantly lower mean Vitamin D levels (56.2%) compared to males (15.3%).
25(OH) Vitamin D is the circulating form of vitamin D which is measurable in the blood. Vitamin D insufficiency has been defined as serum 25-hydroxyvitamin D (25(OH) D) levels below 30 ng/mL and it is common among patients with T2DM. Many studies have revealed that Vitamin D3 (calcitriol) has a role in the synthesis and the secretion of insulin by receptor mediated molecular mechanisms.
Moreover Vitamin D functions are not limited to skeletal health benefits and may extend to preservation of insulin secretion and insulin sensitivity. Studies have revealed the association between vitamin D deficiency and changes in blood glucose and insulin levels as well as sensitivity of the target tissues to insulin .Cross-sectional data provide some evidence that circulating 25-hydroxyvitamin D (25(OH) D) is inversely associated with insulin resistance, although direct measurements of insulin sensitivity are required for confirmation. Available prospective studies support a protective influence of high 25(OH) D concentrations on type 2 diabetes mellitus risk. Vitamin D receptor gene polymorphisms and vitamin D interactions with the insulin like growth factor system may further influence glucose homeostasis. The ambiguity of optimal vitamin D dosing regimens and optimal therapeutic concentrations of serum 25(OH) D limit available intervention studies.
A study found no improvement in glucose tolerance following the administration of two vitamin D doses with an interval of 2 weeks to thirty-seven non-diabetic, vitamin D-deficient adults.
Another study reported a randomised, controlled trial of vitamin D3, three fortnightly doses of 120 000 IU or placebo, in centrally obese Indian men. The subjects were not necessarily insulin resistant, but there was some improvement in postprandial insulin sensitivity following supplementation. A recent systematic review and meta-analysis on the role of vitamin D and calcium in type 2 diabetes conclude that 'there appears to be a relationship' but due to the paucity of data, an understanding of the mechanisms is incomplete.
This study has a novelty in the dosage and the frequency of administration of vitamin D which has not been studied yet. This study will enable to determine the impact of vitamin D replacement on insulin resistance in vitamin D deficient Type 2 diabetic patients and to find any correlation of serum levels of 25 hydroxyvitamin D levels with the degree of insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Experimental | Drug: oral vitamin Dvitamin D arm will receive oral vitamin D in escalating dosage. |
| Conventional | No intervention | –This arm will receive conventional treatment only. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders
- Age 25 to 50 years as type 2 diabetes usually diagnosed in this age range.
- Patients having Type 2 Diabetes Mellitus
- Taking oral antidiabetic medicines
- Serum 25(OH) vitamin D levels below 20ng/ml having no clinical symptoms of vitamin D deficiency.
Key exclusion criteria (7 listed)
- Patients having evidence of liver dysfunction and chronic renal insufficiency because it will alter the metabolism of cholecalciferol.
- Patients having parathyroid dysfunction diagnosed on the basis of blood tests as replacement of vitamin D in these patients is very complex.
- Patients having gastrointestinal surgeries that will alter the absorption of cholecalciferol diagnosed from detailed clinical history and clinical examination.
- Patients having clinical features of gastroparesis diagnosed on the basis of clinical history as it can alter the absorption of vitamin D.
- Patients having erratic control of diabetes requiring multiple hospital admissions for diabetic emergencies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral vitamin DAlso: oral vitamin D 400IUoral Vitamin D 400IU will be given and will be escalated every 2 weeks. | Drug | vitamin D |
Primary outcome
Homeostatic Model Assessment of Insulin Resistance
Time frame: 3 months
insulin resistance reduction to <2.5
1 secondary outcome
Glycated Hemoglobin (HbA1C)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral vitamin D in people with Vitamin D Deficiency and Insulin Resistance, run by King Edward Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic Model Assessment of Insulin Resistance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.