Trial Outcomes & Findings for Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients (NCT NCT01173848)

Last Updated: 2017-04-04

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

19 participants

Primary outcome timeframe

within 24 weeks

Results posted on

2017-04-04

Participant milestones
Measure	Vitamin D2 Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months	Vitamin D3 Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
Overall Study STARTED	8	11
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	4	8

Withdrawal data not reported

Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients

Baseline characteristics by cohort
Measure	Vitamin D2 n=8 Participants Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months	Vitamin D3 n=11 Participants Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants

Timeframe: within 24 weeks

Outcome measures
Measure	Vitamin D2 n=8 Participants Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months	Vitamin D3 n=9 Participants Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
Subjects Achieving Normal Vitamin D Levels	4 participants	4 participants

Serious events: 7 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events
Measure	Vitamin D2 and Vitamin D3 n=19 participants at risk Adverse Events were not logged by study arms. Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months or Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
Musculoskeletal and connective tissue disorders Left Side Back Pain	5.3% 1/19
Endocrine disorders Urinary Tract Infection	5.3% 1/19
Infections and infestations Pneumonia	5.3% 1/19
Cardiac disorders Atrial Fibrillation	5.3% 1/19
Infections and infestations Hospitalization	5.3% 1/19
Endocrine disorders Acute Renal Failure	5.3% 1/19
Metabolism and nutrition disorders Hospitalization for Dehydration	5.3% 1/19

Other adverse events
Measure	Vitamin D2 and Vitamin D3 n=19 participants at risk Adverse Events were not logged by study arms. Patients randomized to take vitamin D2 Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months or Patient's randomized to take Vitamin D3 Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
General disorders Nails Cracking and Falling Off	5.3% 1/19
Gastrointestinal disorders Constipation	15.8% 3/19
General disorders Cystic Fibrosis	5.3% 1/19
General disorders Dizziness	5.3% 1/19
General disorders Worsening Hyperglycemia	5.3% 1/19
Renal and urinary disorders Cloudy Urine	5.3% 1/19
General disorders Hematuria	5.3% 1/19
General disorders Stomach Cramping	5.3% 1/19
Respiratory, thoracic and mediastinal disorders Bronchitis	5.3% 1/19
Metabolism and nutrition disorders High Potassium	5.3% 1/19
Renal and urinary disorders Urinary Tract Infection	5.3% 1/19
General disorders Allergies	5.3% 1/19
General disorders Leg Cramps	5.3% 1/19
General disorders Fatigue	5.3% 1/19
General disorders Acid Reflux	5.3% 1/19
Gastrointestinal disorders Loose Stools	5.3% 1/19

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