scholarly journals Vitamin D supplementation in people with IBS has no effect on symptom severity and quality of life: results of a randomised controlled trial

2021 ◽  
Author(s):  
Claire E. Williams ◽  
Elizabeth A. Williams ◽  
Bernard M. Corfe
Keyword(s):  
Quality Of Life ◽  
Vitamin D ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Community Setting ◽  
Vitamin D Supplementation ◽  
Controlled Study ◽  
Double Blind ◽  
Vitamin D Levels

Abstract Purpose Several small trials suggest a benefit of vitamin D supplementation in irritable bowel syndrome (IBS). The generalisability of these reports is limited by their design and scale. This study aimed to assess whether vitamin D supplementation improved IBS symptoms in a UK community setting. Methods This was a randomised, double-blind, placebo-controlled study. Participants were recruited from the community in winter months between December 2017 and March 2019. 135 participants received either vitamin D (3,000 IU p.d.) or placebo for 12 weeks. The primary outcome measure was change in IBS symptom severity; secondary outcomes included change in IBS-related quality of life. Results The participants were analysed on an intent-to-treat basis. 60% of participants were vitamin D deficient or insufficient at baseline. Although vitamin D levels increased in the intervention arm relative to placebo (45.1 ± 32.88 nmol/L vs 3.1 ± 26.15 nmol/L; p < 0.001). There was no difference in the change of IBS symptom severity between the active and placebo trial arms (− 62.5 ± 91.57 vs – 75.2 ± 84.35, p = 0.426) over time. Similarly there was no difference between trial arms in τhe change in quality of life (− 7.7 ± 25.36 vs – 11.31 ± 25.02, p = 0.427). Conclusions There is no case for advocating use of vitamin D in the management of IBS symptoms. The prevalence of vitamin D insufficiency suggests routine screening and supplementation should be implemented in this population for general health reasons. This trial was retrospectively registered with ISRCTN (ISRCTN13277340) on 24th April 2018 after recruiting had been initiated.

The Safety of Mother’s Milk® Tea: Results of a Randomized Double-Blind, Controlled Study in Fully Breastfeeding Mothers and Their Infants

2018 ◽  
Vol 35 (2) ◽  
pp. 248-260 ◽  
Author(s):  
Carol L. Wagner ◽  
Andrea D. Boan ◽  
Alicia Marzolf ◽  
Carolyn W. Finch ◽  
Kristen Morella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Test Group ◽  
Psychological State ◽  
Controlled Study ◽  
Double Blind ◽  
Mother's Milk ◽  
Mother’S Milk

Background: Various natural products are reported to improve maternal milk supply yet are not necessarily safe for infants. Researchers have not systematically studied galactagogue teas for safety. Research aim: This study evaluates the safety of a galactagogue tea in breastfeeding women and their infants, assessing short- and long-term adverse effects. Methods: Healthy, exclusively/fully breastfeeding women ( N = 60) with no milk insufficiency were randomized into (1) an all-natural tea containing fruits of bitter fennel, anise, and coriander; fenugreek seed; and other herbs (Mother’s Milk® herbal tea; test) group or (2) a lemon verbena leaf (placebo) group. Maternal diaries captured self-reported maternal and infant adverse effects, tea consumed, and perceived infant satisfaction. Maternal quality of life and psychological state were assessed at baseline and 2 and 4 weeks. Poststudy calls assessed adverse effects through the infants’ age of 12 months. Results: No adverse effects attributable to the interventions were reported at any time point. No differences were found between test and placebo groups in sociodemographic characteristics, maternal or infant adverse symptoms, quality of life, breastfeeding self-efficacy, maternal psychological measures, infant growth, and infant satisfaction (all p >.05). Conclusions: This double-blind, randomized controlled trial (RCT) of an herbal galactagogue versus placebo among healthy, exclusively/fully breastfeeding mothers and infants found no adverse events associated with the test tea across the 30-day study or the first year of their infant’s life. This composite tea appears to present no safety risk for mothers or their young babies.

scholarly journals No beneficial effects of vitamin D supplementation on muscle function or quality of life in primary hyperparathyroidism: results from a randomized controlled trial

2015 ◽  
Vol 172 (5) ◽  
pp. 609-617 ◽  
Author(s):  
Lars Rolighed ◽  
Lars Rejnmark ◽  
Tanja Sikjaer ◽  
Lene Heickendorff ◽  
Peter Vestergaard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vitamin D ◽  
Muscle Strength ◽  
Muscle Function ◽  
Postural Stability ◽  
Controlled Trial ◽  
Well Being ◽  
Vitamin D Supplementation ◽  
Beneficial Effects

ContextImpairments of muscle function and strength in patients with primary hyperparathyroidism (PHPT) are rarely addressed, although decreased muscle function may contribute to increased fracture risk.ObjectiveWe aimed to assess the changes in muscle strength, muscle function, postural stability, quality of life (QoL), and well-being during treatment with vitamin D or placebo before and after parathyroidectomy (PTX) in PHPT patients.DesignA randomized placebo-controlled trial.PatientsWe included 46 PHPT patients, mean age 58 (range 29–77) years and 35 (76%) were women.InterventionsDaily treatment with 70 μg (2800 IU) cholecalciferol or placebo for 52 weeks. Treatment was administered 26 weeks before PTX and continued for 26 weeks after PTX.Main outcome measuresChanges in QoL and measures of muscle strength and function.ResultsPreoperatively, 25-hydroxyvitamin D (25OHD) increased significantly (50–94 nmol/l) compared with placebo (57–52 nmol/l). We did not measure any beneficial effects of supplementation with vitamin D compared with placebo regarding well-being, QoL, postural stability, muscle strength, or function. In all patients, we measured marked improvements in QoL, well-being (P<0.01), muscle strength in the knee flexion and extension (P<0.001), and muscle function tests (P<0.01) after surgical cure. Postural stability improved during standing with eyes closed (P<0.05), but decreased with eyes open (P<0.05).ConclusionsPatients with PHPT and 25OHD levels around 50 nmol/l did not benefit from vitamin D supplementation concerning muscle strength, muscle function, postural stability, well-being, or QoL. Independent of preoperative 25OHD levels, PTX improved these parameters.

scholarly journals Effect of Vitamin D on Thyroid Autoimmunity: A Randomized, Double-Blind, Controlled Trial Among Ethnic Minorities

2017 ◽  
Vol 1 (5) ◽  
pp. 470-479 ◽  
Author(s):  
Kirsten V. Knutsen ◽  
Ahmed A. Madar ◽  
Mette Brekke ◽  
Haakon E. Meyer ◽  
Åse Ruth Eggemoen ◽  
...  
Keyword(s):  
Vitamin D ◽  
Middle East ◽  
South Asia ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Thyroid Autoimmunity ◽  
Vitamin D Supplementation ◽  
Double Blind Study ◽  
Double Blind ◽  
Vitamin D Levels

Context: Autoimmune thyroid disorders have been linked to vitamin D deficiency, but an effect of vitamin D supplementation is not established. Objective: Our objective was to test whether vitamin D compared with placebo could reduce thyroid autoantibodies. Design: Predefined additional analyses from a randomized, double-blind, placebo-controlled trial. Setting: The study was conducted in different community centers in Oslo, Norway. Participants: A total of 251 presumed healthy men and women, aged 18 to 50 years, with backgrounds from South Asia, the Middle East, and Africa were included. Intervention: Daily supplementation with 25 µg (1000 IU) vitamin D3, 10 µg (400 IU) vitamin D3, or placebo for 16 weeks. Outcome Measure: Difference in preintervention and postintervention antithyroid peroxidase antibody (TPOAb) levels. Additional outcomes were differences in thyroid-stimulating hormone (TSH) and free fraction of thyroxine (fT4). Results: There were no differences in change after 16 weeks on TPOAb (27 kU/L; 95% CI, −17 to 72; P = 0.23), TSH (−0.10 mU/L; 95% CI, −0.54 to 0.34; P = 0.65), or fT4 (0.09 pmol/L; 95% CI, −0.37 to 0.55; P = 0.70) between those receiving vitamin D supplementation or placebo. Mean serum 25(OH)D3 increased from 26 to 49 nmol/L in the combined supplementation group, but there was no change in the placebo group. Conclusion: Vitamin D3 supplementation, 25 µg or 10 µg, for 16 weeks compared with placebo did not affect TPOAb level in this randomized, double-blind study among participants with backgrounds from South Asia, the Middle East, and Africa who had low vitamin D levels at baseline.

Sign in / Sign up

Export Citation Format

Share Document