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The effect of Vitamin D Supplement on Insulin Resistance and Prevention of Diabetes Mellitus Type 2 in Patients with Pre-diabetes

The effect of Vitamin D Supplement in comparison whit placebo on insulin resistance and prevention of Diabetes Mellitus Type 2 in Patients with Pre-diabetes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013050413223N1
Enrollment
160
Registered
2015-06-16
Start date
2013-04-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre-diabetes (IFG or IGT). Impaired glucose toleranceR73.0Diabetes: chemical latent Impaired glucose tolerance Prediabetes

Interventions

Intervention 1: In Case Group/Vitamin D Group :Vitamin D will be administered as PO (15 Vitamin D pearls). In the first 3 months, the subjects will take one pearl (50,000 IU) every week. Then three
Treatment - Drugs
In Case Group/Vitamin D Group :Vitamin D will be administered as PO (15 Vitamin D pearls). In the first 3 months, the subjects will take one pearl (50,000 IU) every week. Then three pearls will be
In the Control Group, placebo pearls (using paraffin and prepared by Zahravi Pharmaceutical Company) with the same size, shape, and color as the original ones will be administered as PO (15 Vitamin

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: adult patients who are over 18 years old; pre-diabetes (IFG or IGT) and vitamin-D deficiency; obtaine informed consent. Exclusion criteria: overt Diabetes Mellitus; condition which interfere with glucose metabolism (malignancy, CRF, , inflammatory disease...); diseases like thyroid disease or mal-absorption; take medication that interfere with glucose metabolism (Steroids, HRT,Diuretics).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Diabetes(75gr-OGTT):Assessment of fasting plasma glucose after at least 8-hours fasting then 2 hours after administration of 75 gram glucose, Insulin resistance evaluated by calculating HOMA-IR. Timepoint: Befor intervention, 3 and 6 months after intervention. Method of measurement: Fasting plasma sample for evaluation of FPG and Serum insulin,Oral glucose tolerance test(OGTT) with 75gr glucose.

Secondary

MeasureTime frame
Height, weight, BMI, weist circmfrence. Timepoint: Every 3 month. Method of measurement: height (cm), weight (kg), BMI (kg/squired meters), weist circmfrence(cm).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahtab Niroomand

Shahid Beheshti University of Medical Sciences

m.niroomand@sbmu.ac.ir mahtabniroomand@yahoo.com m_jallili@yahoo.com+98 21 8826 2390

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026