Hypothyroidism Treated With Calcitonin
Status: | Recruiting |
---|---|
Conditions: | Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 88 |
Updated: | 6/22/2018 |
Start Date: | June 18, 2018 |
End Date: | December 1, 2019 |
Contact: | Simona Frunza Stefan, M.D. |
Email: | sfrunza@som.umaryland.edu |
Phone: | 443-682-6873 |
Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine
Some people with hypothyroidism have persistent symptoms despite adequate treatment with
thyroid hormones. We are testing whether giving calcitonin to such people will improve their
quality of life.
thyroid hormones. We are testing whether giving calcitonin to such people will improve their
quality of life.
It is known that a proportion of patients with hypothyroidism despite serum TSH levels being
within the normal reference range, may continue to express symptoms of hypothyroidism. Common
symptoms include fatigue, muscle pain, weight gain, and mood changes. Saravanan et al.
reported in a large community-based survey that patients on levothyroxine even with a normal
TSH showed significant impairment in psychological well-being compared with age- and
sex-matched controls. These patients are challenging to manage and are often unhappy with
they care.
Established treatment of hypothyroidism is levothyroxine. Thyroid follicular cells synthesize
and secrete thyroxine and triiodothyronine. However, even when people are receiving adequate
levothyroxine replacement therapy, their quality of life may not improve. Calcitonin (CT) is
also produced by the thyroid gland, parafollicular cells. Their levels are not tested in
hypothyroidism because the exact role of calcitonin in human health and disease is not fully
known. CT has long been thought to play an important role in bone and mineral homeostasis,
particularly with respect to its ability to regulate calcium metabolism. CT has been found in
fish, reptiles, birds, and mammals. Salmon-derived CT is 50-100 times more potent than human
CT. Hence, salmon CT (sCT) has been used for medicinal purposes.
There is a need for further research in order to understand the nature of persisting symptoms
in patients on T4 monotherapy despite a serum TSH within the reference range. Calcitonin has
been shown to alleviate pain in patients with bone or mineral disorders. To date, the use of
calcitonin for relief of hypothyroid symptoms has not been studied.
within the normal reference range, may continue to express symptoms of hypothyroidism. Common
symptoms include fatigue, muscle pain, weight gain, and mood changes. Saravanan et al.
reported in a large community-based survey that patients on levothyroxine even with a normal
TSH showed significant impairment in psychological well-being compared with age- and
sex-matched controls. These patients are challenging to manage and are often unhappy with
they care.
Established treatment of hypothyroidism is levothyroxine. Thyroid follicular cells synthesize
and secrete thyroxine and triiodothyronine. However, even when people are receiving adequate
levothyroxine replacement therapy, their quality of life may not improve. Calcitonin (CT) is
also produced by the thyroid gland, parafollicular cells. Their levels are not tested in
hypothyroidism because the exact role of calcitonin in human health and disease is not fully
known. CT has long been thought to play an important role in bone and mineral homeostasis,
particularly with respect to its ability to regulate calcium metabolism. CT has been found in
fish, reptiles, birds, and mammals. Salmon-derived CT is 50-100 times more potent than human
CT. Hence, salmon CT (sCT) has been used for medicinal purposes.
There is a need for further research in order to understand the nature of persisting symptoms
in patients on T4 monotherapy despite a serum TSH within the reference range. Calcitonin has
been shown to alleviate pain in patients with bone or mineral disorders. To date, the use of
calcitonin for relief of hypothyroid symptoms has not been studied.
Inclusion Criteria:
- Normal TSH on levothyroxine therapy
Exclusion Criteria:
1. pregnant or 6 months post partum
2. Current or previous thyroid cancer
3. Congenital hypothyroidism
4. any tobacco use
5. prescribed proton pump inhibitors
6. prescribed steroids
7. taking armour thyroid, naturethroid, or any dessicated thyroid hormone
8. Unstable medical conditions (CKD, Cirrhosis etc)
9. pituitary disease
We found this trial at
1
site
827 Linden Avenue
Baltimore, Maryland 21201
Baltimore, Maryland 21201
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