Comparison of Different Doses of Vitamin D Supplementation on Glycated Haemoglobin and Blood Glucose Parameters With Type II Diabetes Mellitus Having Vitamin d Deficiency

University of Lahore

Status: Active, not recruiting

Conditions: Diabetes (DM); Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT07321223

IRB-UOL-FAHS/880/2021

Details and patient eligibility

About

COMPARISON OF DIFFERENT DOSES OF VITAMIN D SUPPLEMENTATION ON GLYCATED HEMOGLOBIN (HbA1c) and BLOOD GLUCOSE PARAMETRS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS HAVING VITAMIN D DEFICIENCY"

Enrollment: 108 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients diagnosed of T2DM with the age of 40-70 years from both genders taking only metformin with an Hb1Ac range of 7.5-9% and 25-hydroxy Vitamin D levels (25[OH]D) <20ng/ml. Exclusion Criteria: Individuals

Exclusion Criteria: Individuals with the following conditions will not be included as participants;

• Inability or unwilling to participate or Clinical proximal myopathy
• Renal, hepatic, endocrinological disorders or malignancies on basis of history
• Serum calcium levels > 10.5mg/dl
• Use of insulin or any change in dosage of current hypoglycemic medications during last 3 months
• Intake of vitamin D, calcium or omega 3 supplements within the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Treatment Group-1

Experimental group

Description:

Treatment vitamin D capsules with different dosage (50,000IU) once a week for 90days

Treatment:

Dietary Supplement: Vitamin D

Placebo

No Intervention group

Description:

Only Metformin and Balance Diet

Treatment Group 2

Experimental group

Description:

Treatment vitamin D capsules with different dosage (200000IU) once a week for 90days

Treatment:

Dietary Supplement: Vitamin D