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This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rayaldee | Experimental | Subjects will be instructed to take a loading dose of 10 capsules (300 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. |
|
| Placebo | Placebo Comparator | Subjects will be instructed to take a loading dose of 10 capsules (0 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rayaldee | Drug | 30 mcg calcifediol Extended-Release (ER) Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). | Number and percentage of subjects with serum total 25-hydroxyvitamin D attained at or above 50 ng/mL at Visit 3 (Day 14) | 14 days |
| Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire. | The FLU- PRO Plus© questionnaire was specifically designed and validated to evaluate in clinical trials the presence, severity and duration of symptoms associated with viral infections. It contains 32 items (eg, felt hot, sweating, headache), grouped into 6 domains, that provide a comprehensive evaluation of such symptoms, using 5-point scales (values ranging from 0 to 4) with higher scores indicating worse symptoms. The number of days to resolution of the selected five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering), defined as a reduction in the aggregate symptom score recorded on Day 0 (prior to study drug initiation) by the FLU-PRO Plus© questionnaire to or below 5 for a minimum of three consecutive days. Flu-PRO Plus© was created and supplied by Dr. John Powers and Leidos Biomedical, and the National Institute for Allergy and Infectious Diseases (NIAID). | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of COVID-19 Five Aggregated Symptoms | The number of days to resolution of five symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering), as measured by the FLU-PRO Plus© questionnaire, with resolution defined as the first aggregate symptom score of ≤5 which is maintained for a minimum of three consecutive days, with no individual symptom score >1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akhtar Ashfaq, MD FACP FASN | OPKO Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPKO Investigative Site | San Francisco | California | 94127 | United States | ||
| OPKO Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rayaldee | Subjects will be instructed to take a loading dose of 10 capsules (300 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Rayaldee: 30 mcg Extended-Release (ER) Capsule |
| FG001 | Placebo | Subjects will be instructed to take a loading dose of 10 capsules (0 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Placebo: 0 mcg Extended-Release (ER) Capsule |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis is for the per protocol population, subjects who had a baseline aggregate five symptom score of >5 and did not have a major protocol deviation prior to resolution.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rayaldee | Subjects will be instructed to take a loading dose of 10 capsules (300 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Rayaldee: 30 mcg Extended-Release (ER) Capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). | Number and percentage of subjects with serum total 25-hydroxyvitamin D attained at or above 50 ng/mL at Visit 3 (Day 14) | Per protocol population | Posted | Count of Participants | Participants | 14 days |
|
42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rayaldee | Subjects will be instructed to take a loading dose of 10 capsules (300 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Rayaldee: 30 mcg Extended-Release (ER) Capsule |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
A caveat in the analysis is the variability of 25D at baseline. The study is also limited by timing differences between the onset of symptoms and diagnosis of COVID-19, and between COVID-19 diagnosis and the initiation of treatment among participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| OPKO Health Inc | OPKO Health Inc | 305-575-4100 | contact@opko.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2021 | Mar 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2021 | Mar 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002112 | Calcifediol |
| ID | Term |
|---|---|
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
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| Placebo | Drug | 0 mcg calcifediol Extended-Release (ER) Capsule |
|
| 42 days |
| Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10 | Resolution, defined as the first score of ≤5 which was maintained for a minimum of three consecutive days (without subsequent relapse), for the aggregate five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) and for each individual symptom, defined as a score of 0 or 1, as measured by the FLU-PRO Plus© questionnaire as of Day 10 | 10 days |
| Proportion of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10 | Resolution, defined as the first score of ≤5 which was maintained for a minimum of three consecutive days (without subsequent relapse), for the aggregate five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) and for each individual symptom, defined as a score of 0 or 1, as measured by the FLU-PRO Plus© questionnaire as of Day 10. Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates. | 10 days |
| Number of Participants With Emergency Room/Urgent Care Visits | Number and percentage of subjects with emergency room/urgent care visits | 42 days |
| Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen) | Number and percentage of subjects with oxygen saturation below 94% (without supplemental oxygen) | 42 days |
| Number of Participants With Hospitalizations | Number and percentage of subjects with hospitalization | 42 days |
| Number of Participants With the Requirement for Mechanical Ventilation | Number and percentage of subjects requiring mechanical ventilation | 42 days |
| Number of Participant Deaths | Number and percentage of subjects who died | 42 days |
| Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire | Quality-of-Life (QOL) responses are based on the number of non-missing observations within individual QOL question and visit. Comparisons to baseline are assessed only for subjects who were at risk for improvement. Percentages for the comparisons to baseline are based on the number at-risk for improvement. | 14 days |
| Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period | Clinical course of COVID-19 as a function of Serum Total 25-hydroxyvitamin D concentrations of <50 ng/mL, 50 to 100 ng/mL and >100 ng/mL at Day 14, defined as the proportion of subjects in each treatment group with a total score of ≤5 for the selected five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) using the FLU-PRO Plus© questionnaire. Results were similar for comparisons between treatment groups on Days 7, 14, 21 and 28, and only data for Day 14 is presented. | 14 days |
| Miami |
| Florida |
| 33173 |
| United States |
| OPKO Investigative Site | Miami | Florida | 33185 | United States |
| OPKO Investigative Site | Evanston | Illinois | 60201 | United States |
| OPKO Investigative Site | Laurel | Maryland | 20723 | United States |
| OPKO Investigative Site | Farmington Hills | Michigan | 48334 | United States |
| OPKO Investigative Site | Jackson | Michigan | 49201 | United States |
| OPKO Investigative Site | Sterling Heights | Michigan | 48312 | United States |
| OPKO Investigative Site | Brookhaven | Mississippi | 39601 | United States |
| OPKO Investigative Site | Omaha | Nebraska | 68131 | United States |
| Did not receive the study drug |
|
| BG001 | Placebo | Subjects will be instructed to take a loading dose of 10 capsules (0 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Placebo: 0 mcg Extended-Release (ER) Capsule |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| eGFR (glomerular filtration rate) | Mean | Standard Deviation | mL/min/1.73m^2 |
|
| Serum total 25-hydroxyvitamin D (25D) | Mean | Standard Deviation | ng/mL |
|
| Flu-Pro Plus Aggregate Score | The Flu-Pro Plus Aggregate Score is computed as the summation of scores from the five individual COVID-19 symptoms (Trouble Breathing, Chest Congestion, Dry or Hacking Cough, Body Aches or Pains, and Chills or Shivering). Individual symptom scores range from 0 (symptom-free) to 4 (very severe symptoms). The total score range is from 0 to 20. | Mean | Standard Deviation | scores on a scale |
|
| OG001 |
| Placebo |
Subjects will be instructed to take a loading dose of 10 capsules (0 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Placebo: 0 mcg Extended-Release (ER) Capsule |
|
|
| Primary | Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire. | The FLU- PRO Plus© questionnaire was specifically designed and validated to evaluate in clinical trials the presence, severity and duration of symptoms associated with viral infections. It contains 32 items (eg, felt hot, sweating, headache), grouped into 6 domains, that provide a comprehensive evaluation of such symptoms, using 5-point scales (values ranging from 0 to 4) with higher scores indicating worse symptoms. The number of days to resolution of the selected five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering), defined as a reduction in the aggregate symptom score recorded on Day 0 (prior to study drug initiation) by the FLU-PRO Plus© questionnaire to or below 5 for a minimum of three consecutive days. Flu-PRO Plus© was created and supplied by Dr. John Powers and Leidos Biomedical, and the National Institute for Allergy and Infectious Diseases (NIAID). | Per protocol population | Posted | Mean | Standard Deviation | days | 42 days |
|
|
|
| Secondary | Time to Resolution of COVID-19 Five Aggregated Symptoms | The number of days to resolution of five symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering), as measured by the FLU-PRO Plus© questionnaire, with resolution defined as the first aggregate symptom score of ≤5 which is maintained for a minimum of three consecutive days, with no individual symptom score >1 | Per protocol population | Posted | Mean | Standard Deviation | days | 42 days |
|
|
|
| Secondary | Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10 | Resolution, defined as the first score of ≤5 which was maintained for a minimum of three consecutive days (without subsequent relapse), for the aggregate five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) and for each individual symptom, defined as a score of 0 or 1, as measured by the FLU-PRO Plus© questionnaire as of Day 10 | Per protocol population | Posted | Number | Number of participants | 10 days |
|
|
|
| Secondary | Proportion of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10 | Resolution, defined as the first score of ≤5 which was maintained for a minimum of three consecutive days (without subsequent relapse), for the aggregate five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) and for each individual symptom, defined as a score of 0 or 1, as measured by the FLU-PRO Plus© questionnaire as of Day 10. Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates. | Per protocol population | Posted | Number | Proportion | 10 days |
|
|
|
|
| Secondary | Number of Participants With Emergency Room/Urgent Care Visits | Number and percentage of subjects with emergency room/urgent care visits | Per protocol population | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen) | Number and percentage of subjects with oxygen saturation below 94% (without supplemental oxygen) | Per protocol population | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | Number of Participants With Hospitalizations | Number and percentage of subjects with hospitalization | Per protocol population | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | Number of Participants With the Requirement for Mechanical Ventilation | Number and percentage of subjects requiring mechanical ventilation | Per protocol population | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | Number of Participant Deaths | Number and percentage of subjects who died | Per protocol population | Posted | Count of Participants | Participants | 42 days |
|
|
|
| Secondary | Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire | Quality-of-Life (QOL) responses are based on the number of non-missing observations within individual QOL question and visit. Comparisons to baseline are assessed only for subjects who were at risk for improvement. Percentages for the comparisons to baseline are based on the number at-risk for improvement. | Per protocol population at-risk for improvement from baseline | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Secondary | Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period | Clinical course of COVID-19 as a function of Serum Total 25-hydroxyvitamin D concentrations of <50 ng/mL, 50 to 100 ng/mL and >100 ng/mL at Day 14, defined as the proportion of subjects in each treatment group with a total score of ≤5 for the selected five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) using the FLU-PRO Plus© questionnaire. Results were similar for comparisons between treatment groups on Days 7, 14, 21 and 28, and only data for Day 14 is presented. | Per protocol population minus the number of participants with missing observations (4 participants in each Arm/Group). | Posted | Count of Participants | Participants | 14 days |
|
|
|
| 0 |
| 80 |
| 3 |
| 80 |
| 12 |
| 80 |
| EG001 | Placebo | Subjects will be instructed to take a loading dose of 10 capsules (0 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Placebo: 0 mcg Extended-Release (ER) Capsule | 0 | 80 | 1 | 80 | 12 | 80 |
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Electrocardiogram ST-T segment abnormal | Investigations | Systematic Assessment |
|
| Transaminases increased | Investigations | Systematic Assessment |
|
| Blood parathyroid hormone increased | Investigations | Systematic Assessment |
|
| Blood sodium decreased | Investigations | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | Systematic Assessment |
|
| Electrocardiogram QRS complex abnormal | Investigations | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Stress | Psychiatric disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Worsened compared to baseline |
|
| No charge from baseline |
|
| Missing |
|
| Overall, how were your infection symptoms today compared to yesterday? |
|
|
| How much did your infection symptoms interfere with your usual activities today? |
|
|
| Have you returned to your usual activities today? |
|
|
| In general, how would you rate your physical health today? |
|
|
| Have you returned to your usual health today? |
|
|
| No |
|
| Serum 25D Level 50 - 100 ng/mL |
|
|
| Serum 25D Level >100 ng/mL |
|
|