Antiorbital Calcium in Chronic Conditions

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Dietary Supplement: Ionic Calcium; Dietary Supplement: Calcium Carbonate

• Registration Number: NCT05302713
• Lead Sponsor: National University of Natural Medicine

Brief Summary

The purpose of this study is to determine the mechanistic effects of an ionic calcium supplement in adults with atrial fibrillation, osteoarthritis, and hypertension. The study aims to determine if ionic calcium supplementation affects quality of life, rate of biological aging, bone densitometry, and blood biomarkers of bone metabolism over a six month period compared to non-ionic calcium comparator supplement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-03-31
• Study Start: 2022-04-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-07
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ionic Calcium	Ionic Calcium	Ionic calcium (IC) is a calcium in a free ionic state. Participants will be instructed to take 8mg of IC/60kg body weight dissolved into approximately 500ml of purified water. Participants will titrate their dose at the start of the study as follows: days 1-3: 1 dose per day 30 min prior to a meal; Days 4-6: twice per day, 30 minutes before meals; from day seven onward, the full dosage of three times per day, 30 minutes before meals.
Calcium Carbonate	Calcium Carbonate	Participants will be instructed to take 8mg of calcium carbonate/60kg body weight dissolved into approximately 500ml of purified water. Participants will titrate their dose at the start of the study as follows: days 1-3: 1 dose per day 30 min prior to a meal; Days 4-6: twice per day, 30 minutes before meals; from day seven onward, the full dosage of three times per day, 30 minutes before meals.

Primary Outcome Measures

Name	Time	Method
Rate of Biological Aging	Week 24	Dunedin Pace of Aging Calculated objective measure of the rate of epigenetic aging
Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain	Week 24	Quality of Life

Secondary Outcome Measures

Name	Time	Method
Changes in Cognition	Week 24	MoCA Assessment Score
Changes in Systolic and Diastolic Blood Pressure	Week 24	Objective measure of blood pressure
Changes in Mood	Week 24	Patient Health Questionnaire-9 Score
Changes in Anxiety	Week 24	Generalized Anxiety Disorder-7 Score
Changes in Pain and Disability	Week 24	Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score

Trial Locations

Locations (1)

Helfgott Research Institute; 🇺🇸 Portland, Oregon, United States