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← Monoclonal Gammopathy of Undetermined Significance

NCT00899353 · STUDY IN CONTEXT

Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.

NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods

→

primary · POSTED

Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC. Patients with MGUS or SMM were not enrolled into this study.

Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT00899353
qol key
qol-0000
source section id
NCT00899353-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
measure definition
Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
time frame
baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT00899353
trial label
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0000
    source section id
    NCT00899353-om-0000
    source outcome index
    0
    endpoint
    Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
    endpoint definition
    Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
    time origin
    baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    source section id
    NCT00899353-om-0001
    source outcome index
    1
    endpoint
    The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.
    endpoint definition
    Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC. Patients with MGUS or SMM were not enrolled into this study.
    time origin
    Baseline, month 1, month 2, month 3, month 6, month 9, 12 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Baseline Nuclear Factor Kappa B Activation
    regimen
    Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Nuclear Factor Kappa B Activation Following 3 Capsules Per Day
    regimen
    Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Nuclear Factor Kappa B Activation Following 6 Capsules Per Day
    regimen
    Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Nuclear Factor Kappa B Activation Following 9 Capsules Per Day
    regimen
    Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Nuclear Factor Kappa B Activation Post Supplement
    regimen
    Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Fold Change in ALC-Patient 1
    regimen
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0001#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Fold Change in ALC-Patient 2
    regimen
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0001#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Fold Change in ALC-Patient 3
    regimen
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0001#groups/OG002
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Fold Change in ALC-Patient 4
    regimen
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0001#groups/OG003
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    arm key
    OG004
    arm label
    Fold Change in ALC-Patient 5
    regimen
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0001#groups/OG004
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    arm key
    OG005
    arm label
    Fold Change in ALC-Patient 6
    regimen
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0001#groups/OG005
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    outcome key
    om-0001
    arm key
    OG006
    arm label
    Fold Change in ALC-Patient 7
    regimen
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00899353-om-0001#groups/OG006
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    harm key
    EG000
    source section id
    NCT00899353-ae
    event group key
    EG000
    event group label
    Adverse Effects
    serious affected
    0
    serious at risk
    16
    other affected
    5
    other at risk
    16
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-monoclonal-gammopathy-of-undetermined-significance
    nct id
    NCT00899353
    qol key
    qol-0000
    source section id
    NCT00899353-om-0000
    source outcome index
    0
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
    measure definition
    Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
    time frame
    baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice