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Effect of Vitamin D Replacement on Insulin Sensitivity

T

Texas Tech University Health Sciences Center

Status and phase

Completed
Phase 1

Conditions

Insulin Sensitivity

Treatments

Drug: Ergocalciferols
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01268111
TTUHSC-VitD-RBP4

Details and patient eligibility

About

Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

    1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months

Exclusion criteria

    1. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.

    2. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.

    3. Bariatric surgery or liposuction 4. Unintentional weight loss >5% of the body weight in last 3 months 5. Chronic smokers (> 1 pk/d for 10 years) 6. Alcohol use > 2 drinks/day

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

12 participants in 2 patient groups, including a placebo group

Vitamin D
Experimental group
Description:
ERgocalcifoerol 50,000 units q weekly for 8 weeks
Treatment:
Drug: Ergocalciferols
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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