Efficacy Of Ergocalciferol In Adults According To BMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-04-30

Brief Summary

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Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES data collection there was a near doubling of patients with vitamin D deficiency in 10 years. Vitamin D deficiency is associated with several adverse outcomes such as increased fractures, certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The increasing prevalence of vitamin D deficiency has been attributed to the increasing prevalence of obesity. Several studies have shown that obese patients have lower 25-OH vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more vitamin D compared to nonobese patients. The most commonly prescribed medication to replete vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been published to evaluate a standard protocol in the treatment of vitamin D insufficiency in adults.

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Detailed Description

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Conditions

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Obesity Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMI <25

Normal BMI

Group Type EXPERIMENTAL

Ergocalciferols

Intervention Type DRUG

Treatment 1- 400,000 IU

Ergocalciferols

Intervention Type DRUG

Treatment 2- 800,000 IU

BMI 25-35

Overweight and obese by BMI

Group Type EXPERIMENTAL

Ergocalciferols

Intervention Type DRUG

Treatment 1- 400,000 IU

Ergocalciferols

Intervention Type DRUG

Treatment 2- 800,000 IU

BMI >35

Obese by BMI

Group Type EXPERIMENTAL

Ergocalciferols

Intervention Type DRUG

Treatment 1- 400,000 IU

Ergocalciferols

Intervention Type DRUG

Treatment 2- 800,000 IU

Interventions

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Ergocalciferols

Treatment 1- 400,000 IU

Intervention Type DRUG

Ergocalciferols

Treatment 2- 800,000 IU

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Study subjects have to be between the ages of 18 to 65 with a serum 25OHD level less than 20 ng/ml.

Exclusion Criteria

* Participants will be excluded if they have any of the following:

1. Due to the inaccuracies of BMI in patients with increased muscle mass, in group with a BMI 25-35: men with a waist circumference \< 90 cm ; women \< 80 cm
2. Chronic liver disease defined by any clinical or a history of serum AST or ALT \> 2 times ULN
3. Kidney disease defined as a GFR \<60 ml/min
4. Sarcoidosis
5. Any known malignancy
6. Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass
7. Primary hyperparathyroidism or hypercalcemia,
8. Patients that are pregnant or considering pregnancy.
9. Patients taking certain medications such as glucocorticoids, anti-seizure medications such has phenobarbital or phenytoin or patients taking antiviral medications for HIV as these are known to cause vitamin D deficiency
10. Individuals excluded from having a DXA scan

Study participants will be excluded from having a DXA scan if any of the following:

1. Any amputation of a extremity including toes
2. If they have a pacemaker, automatic defibrillator, coronary stents or metal suture material in the heart
3. If they have artificial joints, pins, plate or any other type of metal objects
4. If they have received contrast material such as barium in the past 7 days
5. If they have had a nuclear medicine study in the past 3 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes