Abstract
Objective
Vitamin D deficiency affects parathyroid hormone levels and is endemic in the American population due to diet and lifestyle. The aim of this study was to evaluate a treatment algorithm using weekly doses of 50,000 IU of Vitamin D 2 for thyroid and parathyroid surgery patients.
Study Design
Prospective, non-randomized.
Setting
University health sciences center.
Subjects and Methods
Patients at a thyroid center being treated for benign and malignant thyroid diseases or parathyroid disease. Subjects with total vitamin D levels less than 30 ng/dl were prospectively treated with weekly doses of 50,000 IU of vitamin D 2 (D 2 ) for durations dependent upon initial vitamin D (25-hydroxyvitamin D) levels. Vitamin D levels were measured after the treatment intervals and change in levels from baseline was determined.
Results
Subjects receiving 8 weeks of therapy demonstrated an average increase in vitamin D level of 13.4 ng/ml, 10 weeks of therapy showed an increase of 16.35 ng/ml, and 12 weeks showed an average increase of 21.6 ng/ml. The treatment groups had success rates of 82%, 75%, and 71% after 8, 10, and 12 weeks of therapy respectively. When only compliant patients were evaluated (defined as greater than 3-ng/ml increase after therapy), the success rates after 8, 10, and 12 weeks increased to 95%, 79%, and 71% respectively.
Conclusions
A simple algorithm using 50,000 IU of vitamin D 2 corrects its deficiency in the majority of subjects treated. This is a simple method of treatment for thyroid and parathyroid patients who are vitamin D deficient. Thyroid and parathyroid conditions are frequently treated by otolaryngologists and vitamin D deficiency can complicate their diagnosis and/or management.
1
Introduction
There is a marked increase in information and interest concerning the effects of vitamin D as an agent for the possible prevention and/or treatment of many common ailments, in addition to its value in bone health. There is growing clinical evidence that vitamin D may prevent the development of multiple sclerosis, diabetes, rheumatoid arthritis, congestive heart failure, and some anecdotal evidence for preventing schizophrenia and depression . Methods for increasing vitamin D levels have long included food sources, sun exposure, or supplementation. Most individuals will not consume an adequate amount of vitamin D through food sources. This is exacerbated by the current emphasis on protection from exposure to the sun’s UV rays. These factors highlight the importance of an efficient method of correcting vitamin D insufficiency by supplementation. Vitamin D supplementation is not a novel idea as health care professionals have been administering oral forms of vitamin D for many years; however no universally accepted treatment guideline has been established that recommends dosage and/or time period of treatment to reach normal levels.
The present study prospectively examined the efficacy of weekly doses of 50,000 IU of vitamin D 2 in correcting vitamin D deficiency, with treatment duration dependent upon the initial vitamin D level. The study population consisted of patients presenting to a thyroid and parathyroid surgery center at a university health sciences center with benign and malignant diseases. This experience was gained by treating a population of patients undergoing thyroid and parathyroid surgery and closely monitoring their calcium, parathyroid hormone and 25 OH vitamin D levels. Similar populations may be encountered in selected otolaryngology practices. Using this algorithm, normal vitamin D levels were attained in the majority of study subjects.
2
Methods
The treatment algorithm was evaluated in the Thyroid Center at the University of Arkansas for Medical Sciences. The subjects were seen primarily for thyroid and parathyroid disorders. The study was approved by the institutional review board at the University of Arkansas for Medical Sciences. Subjects were included in the study if they had no signs, symptoms, or history of malabsorption, were identified as vitamin D deficient (initial 25(OH) D level < 30 ng/ml) and had a post-treatment level drawn within 4 weeks of completing the protocol. The time frames of treatment in our protocol were based upon our previous experience treating vitamin D deficiency. Data collected also included the subject’s age, ethnicity, and BMI. Subjects were assigned to treatment groups based on initial 25(OH) D levels. Patients presenting with levels at 1–10 ng/ml were treated with 50,000 IU of D 2 orally for 12 weeks, 11–20 ng/ml were treated with 50,000 IU for 10 weeks, and 21–30 ng/ml were treated for 8 weeks. A final total 25(OH) D level greater than 30 ng/ml was considered sufficient, and patients were instructed to continue vitamin D 3 therapy of 1000 IU daily in order to remain sufficient. Subjects were considered non-compliant if there was less than a 3-ng/ml rise in total vitamin D level after the protocol had ended.
2
Methods
The treatment algorithm was evaluated in the Thyroid Center at the University of Arkansas for Medical Sciences. The subjects were seen primarily for thyroid and parathyroid disorders. The study was approved by the institutional review board at the University of Arkansas for Medical Sciences. Subjects were included in the study if they had no signs, symptoms, or history of malabsorption, were identified as vitamin D deficient (initial 25(OH) D level < 30 ng/ml) and had a post-treatment level drawn within 4 weeks of completing the protocol. The time frames of treatment in our protocol were based upon our previous experience treating vitamin D deficiency. Data collected also included the subject’s age, ethnicity, and BMI. Subjects were assigned to treatment groups based on initial 25(OH) D levels. Patients presenting with levels at 1–10 ng/ml were treated with 50,000 IU of D 2 orally for 12 weeks, 11–20 ng/ml were treated with 50,000 IU for 10 weeks, and 21–30 ng/ml were treated for 8 weeks. A final total 25(OH) D level greater than 30 ng/ml was considered sufficient, and patients were instructed to continue vitamin D 3 therapy of 1000 IU daily in order to remain sufficient. Subjects were considered non-compliant if there was less than a 3-ng/ml rise in total vitamin D level after the protocol had ended.
3
Results
Seventy-six subjects were included in the study. Eighty-eight percent were white, 11% were black, and 91% were female. The average age was 61.9 years (± 1.9 years), and average body mass index was 30.0 (± 0.9). Forty-nine (64%) subjects were mildly deficient at the initiation of treatment (21–30 ng/ml), 20 (26 %) were deficient (11–20 ng/ml) and only 7 (9%) were severely deficient (1–10 ng/ml). Treatment of all three groups established sufficient 25(OH)D levels in the majority of subjects. As shown in Fig. 1 , subjects receiving 8 weeks of therapy demonstrated an average increase of 13.4 ng/ml, 10 weeks of therapy produced an increase of 16.3 ng/ml, and 12 weeks of therapy showed an average increase of 21.6 ng/ml. As shown in Fig. 2 , the treatment groups had success rates of 95%, 79%, and 71% at 8, 10, and 12 weeks respectively without inclusion of non-compliant patients and success rates of 82%, 75%, and 71% respectively with the inclusion of non-compliant patients. Non-compliance was uncommon with only 8 patients (10%) demonstrating 25(OH)D levels that either decreased or failed to rise by more than 3 ng/ml above the level drawn at therapy onset. Non-compliance was similar in all groups: 14 %, 5% and 0% in patients mildly deficient, deficient and severally deficient groups respectively. No patients in the study had signs or symptoms that would indicate malabsorption issues.
