Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Thyroid function
研究概览
简要总结
A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.
详细描述
To date there is debate regarding the best timing of L-thyroxine administration during Ramadan as sufficient evidence is lacking. This study aims to compare two-time points of levothyroxine intake during Ramadan focusing on change in TSH, satisfaction and compliance.
A prospective, randomized, open label, multicenter Study. The first group will be will be instructed to take their L-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume Iftar meal. The second group (pre-Fajer prayer), patients are going to be instructed to take L-thyroxin dose immediately before start of fast, i.e. Alfajer (dawn) regardless of Suhoor time. The values of Thyroid stimulating hormone (TSH) will be measured two weeks before Ramadan, and 2-4 weeks after Ramadan for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.
- •Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.
排除标准
- •Pregnant or lactating women.
- •Uncontrolled thyroid function test three months prior Ramadan.
- •Thyroid cancer patients who require suppressed TSH.
- •Central Hypothyroidism, patient with acute illness.
- •Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries
- •Use of certain Medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, PPI, rifampicin, and antiepileptic medications
- •Renal or hepatic disease:
- •Creatinine clearance <0.6 ml/s or serum creatinine ≥200 μmol/l
- •Alanine transferase ≥2.5 times the upper limit of normal
- •Active liver disease including jaundice, chronic hepatitis, previous liver transplant
- •Unwillingness to be randomized or to sign informed consent
- •Known Psychiatric Disorders
- •Known uncontrolled substance abuse or alcoholism
研究组 & 干预措施
Pre-Iftar (Breaking the fast)
To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast).
干预措施: L-Thyroxine time B (5-15 minutes Before dawn) (Other)
Pre-Fajr (Starting the fast)
To take thyroxine immediately before start of fast at predawn time regardless of last meal time.
干预措施: L-Thyroxine time B (5-15 minutes Before dawn) (Other)
结局指标
主要结局
Thyroid function
时间窗: 6 - 8 weeks
Change in TSH level
次要结局
未报告次要终点