Effect of Vitamin C Supplementation in Patients With Primary Hypothyroidism

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Thyroid disease affects almost a quarter of a billion individuals worldwide and more than 50% of them being not aware of this condition.1,2 The commonest thyroid disease is iodine deficiency related thyroid dysfunction with nearly 2 billion people around the globe at risk with insufficient iodine intake.3 Autoimmune thyroid disorders are commonest cause of thyroid dysfunction in iodine sufficient parts of the world.4 Sub-optimally or untreated hypothyroidism can lead to cognitive decline, dyslipidemia, hypertension, infertility as well as cardiovascular and neuromuscular problems.5,6,7 The prevalence of hypothyroidism can vary in general population with up-to 5.3% people with overt hypothyroidism based on studies from the West,8 with estimated 10% of the population having subclinical hypothyroidism globally.9 In the gulf region however, there are no national studies that provide insight into exact prevalence of hypothyroidism, however some cross-sectional screening studies indicate frequency of hypothyroidism to be as high as 5-10%.10,11

Levothyroxine is a synthetic hormone with structure similar to naturally occurring thyroxine, and it is used as replacement monotherapy of hypothyroidism.12 It is mainly absorbed via small intestine.13 The optimal daily levothyroxine dosage requirement is 1.6 microgram/kg body weight/day, which can normalize TSH in most patients, however many studies indicate that nearly half the patient on replacement therapy may not attain a normal TSH and require further doses, possibly due to interference or malabsorption.13,14,15 multiple dose change and repeated diagnostic procedures in these patients can not only increased health costs but increased of ensuing complications secondary to sub-optimally controlled hypothyroidism.7,16 Instead of increasing levothyroxine doses and getting variable response, recent study have shown improvement in thyroid function by adding on vitamin C alongside levothyroxine dose, albeit only in a specific subset of patient having gastritis. The effect of Vitamin C on improving levothyroxine also been shown to be effective over a short period in a non-randomized, non-controlled setting. Our study aims to investigate whether addition of vitamin C to levothyroxine can improve the biochemical and clinical thyroid status in a randomized controlled setting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Adnan Agha
• Treatments: Ascorbic Acid; Vitamins

Criteria

Inclusion Criteria:

• Age > 18; both male or female

• Diagnosed to have Primary hypothyroidism > 6 months.

• Under follow up in Endocrine clinic in Tawam hospital during the 6 months

• No evidence of secondary hypothyroidism (no pituitary problems/surgery or thyroid surgery/ablation)

• TSH > 4 despite being on > 1.6 ug/kg/day of Levothyroxine for more than 8 weeks

Exclusion Criteria:

• Presence of coeliac disease

• Presence of selenium or iodine deficiency

• Gastric/intestinal resection surgery or confirmed malabsorption syndromes

• Known mental health issues affecting compliance

• Patient unable to consent.

• Overt biochemical hypothyroidism with TSH > 20 or T4 < 6