Trial Outcomes & Findings for Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure (NCT NCT01474486)
NCT ID: NCT01474486
Last Updated: 2021-06-10
Results Overview
Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram. The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening.
COMPLETED
NA
40 participants
Change from baseline in Left Ventricular Ejection Fraction at 6 months
2021-06-10
Participant Flow
40 participants consented to the study. Twelve were screen failures and six withdrew following consent but prior to their first visit when baseline data collection would have taken place and the intervention would have started. Therefore twenty-two participants received the intervention. The participants served as their own control, so there is only one arm of the study.
Participant milestones
| Measure |
Micronutrients
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
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|---|---|
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Overall Study
STARTED
|
28
|
|
Overall Study
Treated
|
22
|
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Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Micronutrients
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
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|---|---|
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Overall Study
Death
|
2
|
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Overall Study
Withdrawal by Subject
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4
|
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Overall Study
Withdrawn by the PI: One didn't understand what he consented for and one required surgery.
|
2
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Baseline Characteristics
Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
Baseline characteristics by cohort
| Measure |
Micronutrients
n=22 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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10 Participants
n=5 Participants
|
|
Age, Continuous
|
64.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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22 participants
n=5 Participants
|
|
Minnesota Living with Heart Failure Questionnaire
|
15.0 units on a scale
n=5 Participants
|
|
Serum vitamin B1
|
122 nmoL/L
n=5 Participants
|
|
Serum B6
|
7.6 ng/mL
n=5 Participants
|
|
Serum Zinc
|
76.0 mcg/dL
n=5 Participants
|
|
Serum Vitamin D
|
32.1 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in Left Ventricular Ejection Fraction at 6 monthsPopulation: All individuals in whom either baseline or 6 month measures were obtained.
Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram. The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening.
Outcome measures
| Measure |
Micronutrients
n=21 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
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|---|---|
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Change in Left Ventricular Ejection Fraction by Echocardiogram
|
1.1 Percent
Standard Error 2.3
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PRIMARY outcome
Timeframe: Change from baseline in Left Ventricular Ejection Fraction at 6 monthsPopulation: All persons with at least one measurement of LVEF by MRI.
Left Ventricular Ejection Fraction Measured by Magnetic Resonance Imaging (MRI). The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening.
Outcome measures
| Measure |
Micronutrients
n=13 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
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|---|---|
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Change in Left Ventricular Ejection Fraction as Measured by Magnetic Resonance Imaging (MRI)
|
3.8 Percent
Standard Error 3.4
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SECONDARY outcome
Timeframe: Change from baseline Quality of Life at 3 monthsPopulation: All individuals with either baseline or 3 month measure of Quality of Life.
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 -5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 3 months was calculated by subtracting the 3 month score from the baseline score. A lower score at 3 months indicates better QOL and a high score at 3 months indicates a worse QOL.
Outcome measures
| Measure |
Micronutrients
n=22 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
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|---|---|
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Change in Quality of Life
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-8.3 units on a scale
Standard Error 6.9
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SECONDARY outcome
Timeframe: Change from baseline in nutritional status at 3 monthsPopulation: All with both baseline and 3 month assessment of nutritional status
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 3 months.
Outcome measures
| Measure |
Micronutrients
n=22 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
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|---|---|
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Nutritional Status
|
0 score on a scale
Interval -1.0 to 0.0
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SECONDARY outcome
Timeframe: Change from baseline quality of life at 6 monthsPopulation: All individuals with either a baseline or six month measure of Quality of Life.
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 6 months was calculated by subtracting the 6 month score from the baseline score. A lower score at 6 months indicates better QOL and a higher score at 6 months indicates a worse QOL.
Outcome measures
| Measure |
Micronutrients
n=22 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
|
|---|---|
|
Change in Quality of Life
|
-5.9 units on a scale
Standard Error 7.0
|
SECONDARY outcome
Timeframe: Change from baseline quality of life at 12 monthsPopulation: All in whom either Baseline or 12 month Quality of Life was assessed.
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 12 months was calculated by subtracting the 12 month score from the baseline score. A lower score at 12 months indicates better QOL and a higher score at 12 months indicates a worse QOL.
Outcome measures
| Measure |
Micronutrients
n=22 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
|
|---|---|
|
Change on Quality of Life
|
2.6 units on a scale
Standard Error 8.8
|
SECONDARY outcome
Timeframe: Change from baseline in nutritional status at 6 monthsPopulation: All individuals with both baseline and 6 month assessment of nutritional status.
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 6 months.
Outcome measures
| Measure |
Micronutrients
n=20 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
|
|---|---|
|
Nutritional Status
|
0 score on a scale
Interval -0.5 to 0.0
|
SECONDARY outcome
Timeframe: Change from baseline in nutritional status at 12 monthsPopulation: All individuals with both baseline and 12 month assessments of nutritional status.
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 12 months.
Outcome measures
| Measure |
Micronutrients
n=15 Participants
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b
|
|---|---|
|
Nutritional Status
|
0 score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Micronutrients
Serious adverse events
| Measure |
Micronutrients
n=22 participants at risk
Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid \& pyridoxine, 100 microgram (mcg) folic acid, \& 50 mcg cyanocobalamin (B12) \& biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
|
|---|---|
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Cardiac disorders
All Cause Mortality
|
4.5%
1/22 • Number of events 1 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Cardiac disorders
All cause mortality
|
4.5%
1/22 • Number of events 1 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Cardiac disorders
Serious Adverse Event
|
4.5%
1/22 • Number of events 2 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Infections and infestations
Serious Adverse Events
|
4.5%
1/22 • Number of events 3 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Infections and infestations
Serious Adverse Event
|
4.5%
1/22 • Number of events 1 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Gastrointestinal disorders
Adverse Events
|
4.5%
1/22 • Number of events 1 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
General disorders
Serious Adverse Event
|
4.5%
1/22 • Number of events 1 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Blood and lymphatic system disorders
Serious Adverse Event
|
4.5%
1/22 • Number of events 1 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Vascular disorders
Serious Adverse Event
|
4.5%
1/22 • Number of events 1 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
Other adverse events
| Measure |
Micronutrients
n=22 participants at risk
Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid \& pyridoxine, 100 microgram (mcg) folic acid, \& 50 mcg cyanocobalamin (B12) \& biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
|
|---|---|
|
Metabolism and nutrition disorders
Other
|
54.5%
12/22 • Number of events 17 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Gastrointestinal disorders
Other
|
9.1%
2/22 • Number of events 2 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
Eye disorders
Other
|
9.1%
2/22 • Number of events 2 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
|
General disorders
Other
|
9.1%
2/22 • Number of events 2 • The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place