CClinicalTrials.gg
Sign In
TerminatedNCT02435771Updated May 11, 2017

Efficacy Of Ergocalciferol In Adults According To BMI

A Phase 4 interventional study of Ergocalciferols and Ergocalciferols in Obesity and Vitamin D Deficiency, sponsored by Walter Reed National Military Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-11.

Sponsored by Walter Reed National Military Medical Center · Phase 4, Interventional, and Treatment

Why this study was terminated
failed to meet enrollment goals
Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity
  • Vitamin D Deficiency

Browse trials for

03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 44 is below the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Walter Reed National Military Medical Center is the lead sponsor of 73 studies on the registry; 19 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    BMI <25

    Normal BMI

    Drug: Ergocalciferols

  • Experimental
    BMI 25-35

    Overweight and obese by BMI

    Drug: Ergocalciferols

  • Experimental
    BMI >35

    Obese by BMI

    Drug: Ergocalciferols

Interventions

  • DrugErgocalciferols

    Treatment 1- 400,000 IU

  • DrugErgocalciferols

    Treatment 2- 800,000 IU

06

What researchers measure

Primary outcomes

  1. serum 25-hydroxy-vitamin D level

    Time frame: 12 weeks

07

Study locations

1 site
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02435771
Lead sponsor
Walter Reed National Military Medical Center
Responsible party
Sponsor
First posted
May 6, 2015
Start date
Jul 2011
Primary completion
Apr 2017
Completion
Apr 2017
Last update
May 11, 2017

Study contacts

Alicia L Warnock, MD
principal investigator · WRNMMC-B
Patrick W Clyde, MD
study director · WRNMMC-B
Vinh Mai, MD
study chair · WRNMMC-B
Verna Parchment
study chair · WRNMMC-B

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vitamin D Deficiency→

Other studies from this sponsor

Walter Reed National Military Medical Center

Start the discussion