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Vitamin D3: Identification of central nervous system targets using high-technology functional MRI (D-LIGHTFUL)

Vitamin D3: Identification of central nervous system targets using high-technology functional MRI (D-LIGHTFUL) - D-LIGHTFUL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48648
Enrollment
60
Registered
2018-07-05
Start date
2019-02-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endocriene aandoeningen, obesitas Obesity

Interventions

All participants will receive in random order (after the baseline mri) a single-dose of calcitriol 4µg (= intervention) and 0.9% NaCl (= placebo). These interventions will be scheduled approximately

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age between 18 - 35 years - Ability to provide informed consent - Right-handedness - Stable weight (74 pmol/l at screening

Exclusion criteria

Exclusion criteria: - Any medical or psychiatrical disorder (except stable obesity-related glucose intolerance, hypertension, dyslipidemia and/or controlled hypothyroidism) - Subjects taking any of the following medications: anticonvulsants, corticosteroids, digitalis, magnesium-containing preparations (e.g. antacids), thiazide-diuretics, phosphodiesterase inhibitors, serotonergic medications (e.g. SSRI, SNRI, MAO inhibitors, buproprion, tricyclic antidepressants, St. John*s Wort), codeine (CYP2D6 inhibition), tamoxifen, timolol, warfarin, exogenous insulin, GLP-1 agonists, DPP4 inhibitors, SGLT2 inhibitors, beta-blockers, homeopathic supplements - The use of weight loss agents (e.g. orlistat, phentermine, topiramate, fenfluramin, dexfenfluramine, amphetamines, GLP-1 agonists) or use within 3 months prior to study - Weight loss surgery or gastrectomy - Childhood-onset obesity - Breakfast skippers - Shift workers - Contraindication to MRI scanning (e.g. claustrophobia, pacemaker, metal IUD) - Significant sensory or motor impairment - Subjects who cannot adhere to the experimental protocol for any reason

Design outcomes

Primary

MeasureTime frame
The effect of calcitriol on brain activity in the hypothalamus and reward areas as well as functional connectivity as measured by fMRI during food stimuli.

Secondary

MeasureTime frame
The effect of calcitriol on: - Subjective (VAS) scores of hunger and satiety - Neuropsychological functioning and feeding behavior characteristics as assessed by questionnaires - Objective scores of hunger and satiety as measured during an ad-libitum buffet meal - The gut microbiota and its association with changes in fMRI responses - Circulating levels of glucose, insulin, and hormones

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)