Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.

Placebo: same number of tablets as in the active comparator arm, in 4 weeks

Fatigue

Thiamine

Placebo

Aarhus University Hospital

Thiamin Against Robust IBD Fatigue

Change in levels of fatigue measured by the Inflammatory Bowel Disease Fatigue Scale (IBD-F). Section I of the scale measures the severity of fatigue on a scale from 0-20, where 20 is maximum fatigue. A change in IBD-F score of 3 points or more is regarded as a clinical relevant change.

Changes in Health-Related Quality of Life, measured by the generic EQ-5D Tool (mainly the VAS-scale (0-100, where100 is best).

Changes in Health-Related Quality of Life, measured by the disease specific Short Health Scale (SHS). SHS comprises 4 questions regarding disease related quality of life on VAS-scales (0-10, where 10 is worst).

University of Aarhus

Behavioral: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)

Only regular health message from government health services

Maltreatment

The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)

Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice

Runyan, Child-Maltreatment-Research-L (CMRL) list serve, 2014

Uddin MK, Islam MT, Asaduzzaman M. Perceived Stress and Self-Esteem as Significant Predictors of Cigarette Smoking Behavior of Bangladeshi Male Adults.

World Health Organization 2008, The Global Burden of Disease 2004 update

Fahmida Tofail, PhD

Reduce Childhood Maltreatment and Promote Development

Effect of Integrated Management of Childhood Maltreatment, Maternal Depression, Psychosocial Stimulation and Nutritional Intervention on Child Development - A Randomized Controlled Trial

cognitive development will be measured by Bayley tools. All individuals score will be aggregated in to composite score of cognitive,motor, language and social-emotional development of children

The International Society for the Prevention of Child Abuse and Neglect (ISPCAN) has developed ISPCAN Child Abuse Screening Tool- Parent Version (ICAST-P) will be used for measuring the severity of maltreatment calculating score.

Height will be measure in centimeter through World Health Organization (WHO) guideline.

Weight will be measure in gram through World Health Organization (WHO) guideline.

Head circumference will be measure in centimeter through World Health Organization (WHO) guideline.

The Hematological measurement will be measured as Hb per g/dl ,

folic acid status will be measured as ng/ml

The Hematological measurement will be measured as Retinol per Mg /ml

The Hematological measurement will be measured as STfR per Mg/ml

the Rosenberg Self Esteem Scale (Rosenberg, 1965), the most widely used measure of self esteem for research purposes and Measurement of maternal depressive symptoms will be done using Center for Epidemiologic Studies Depression Scale (CESD)

A questionnaire will be used to measure positive parenting

International Centre for Diarrhoeal Disease Research, Bangladesh

UBS Optimus Foundation

Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)

Typical physician recommendations for MS.

Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)
Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)

Modified Paleo Diet Intervention (MPDI)

Usual Care

Total

Sex: Female, Male

Higher score (1-7) indicates more fatigue. The total score is the average of 9 questions.

Fatigue Severity Scale (FSS)-9

Estimates exercise tolerance in metabolic equivalents (METs). A higher score (1-13) indicates better exercise tolerance.

Veterans Specific Activity Questionnaire (VSAQ)

Quantitative mobility and leg function performance test based on a timed 25-foot walk. Less time to complete indicates less physical fatigue.

Timed 25-Foot Walk (25-FW)

On a start command, a stopwatch is started, the patient picks up nine pegs one at-a-time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at-a-time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged.

9-Hole Peg Test (9-HPT) (dominant)

9-Hole Peg Test (9-HPT) (nondominant)

Total number correct out of 60 possible answers. A higher score indicates reduced cognitive fatigue.

Paced Auditory Serial Addition Test (PASAT)

Assesses submaximal aerobic capacity/endurance through measuring distance walked in 6 minutes. Greater distance indicates less physical fatigue.

6 Minute Walk (6-MW)

This 54-item instrument generates two composite summary scores, physical health and mental health. Higher scores (0-100) indicate improved health.

Multiple Sclerosis Quality of Life-54 (MSQOL-54) (physical)

Multiple Sclerosis Quality of Life-54 (MSQOL-54) (mental)

B-1 (thiamine)

B-9 (folate)

B-12 (cobalamin)

K (pg/mL)

Hs-CRP

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (a) daily life as measured by the Fatigue Severity Scale (FSS) score.
A 9-item sel-report questionnaire related to how fatigue interferes with certain activities and rates its severity, items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score is 63. Higher the score indicates greater fatigue severity.

Change in Fatigue Severity Scale (FSS)-9 Score

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (b) cognitive fatigue as measured by the Paced Auditory Serial Addition Test (PASAT) score.
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT (0-60) is the total number correct out of 60 possible answers.

Change in Paced Auditory Serial Addition Test (PASAT) Score

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (c) physical fatigue as measured by the 6-minute (m) walk (6-MW).
Timed 6-minute walk (6-MW): a submaximal measure of gait velocity and endurance over a distance (m) walked in 6 minutes.

Change in 6-minute Walk (6-MW) Distance

Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (d) physical fatigue as measured by the 25-ft walk (25-FW; (s).
Timed 25-Foot Walk (T25-FW): a quantitative test of maximal walking velocity, mobility, dynamic balance and leg function. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and as safely, as possible. The time is recorded from the first step across the line and ends when the patient crosses the same foot over the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.

Change in (25-FW) 25-ft Walk Time

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by: Multiple Sclerosis Quality of Life-54 (MSQOL-54) Mental and Physical Health scores.
Multiple Sclerosis Quality of Life-54 (MSQOL-54): a multidimensional health-related quality of life survey that combines both generic and MS-specific items into a single instrument. Higher scores (0-100) indicate improved health.

Quality of Life (MSQOL-54)

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-1 (thiamine) blood serum measures.

Quality of Life (Vitamin B-1 Blood Serum Measures)

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-9 (folate) blood serum measures.

Quality of Life (Vitamin B-9 Blood Serum Measures)

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by blood serum measures: vitamin B-12 (cobalamin) and vitamin K.

Quality of Life (Vitamins B-12 and K Blood Serum Measures)

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by homocysteine (HCY) blood serum measures.

Quality of Life (Homocysteine Blood Serum Measures)

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by C-reactive protein (hs-CRP) blood serum measures.

Quality of Life (C-reactive Protein Blood Serum Measures)

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the 9-Hole Peg Test (9-HPT).
9-Hole Peg Test: a brief, standardized, quantitative test of upper extremity function. The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes (Rolyan 9-Hole Peg Test Kit - Model A8515). On a start command a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The score for the 9-HPT is an average of the two trials for each hand.

Quality of Life (9-HPT)

Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the Veterans Specific Activity Questionnaire (VSAQ).
Veterans Specific Activity Questionnaire (VSAQ): a self-reported survey instrument that serves as a strong predictor of both measured and predicted exercise capacity. Subjects identify a series of activities that they can complete on a typical day (scaled 1-11 for estimated metabolic equivalents (METs)), higher METs indicate increased exercise capacity.

Quality of Life (VSAQ)

Overall Study

Amanda Irish

Multiple Sclerosis, Relapsing-remitting

Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)

Modified Paleo diet

University of Iowa

Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis

Randomized Control Trial Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Data from this study are complex and housed in different formats, but are available by contacting the corresponding author.

thiamine/fatigue

Thiamin Against Robust IBD Fatigue

Reduce Childhood Maltreatment and Promote Development

Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis

La base de données d'herbes médicinales la plus complète soutenue par la science