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Clinical, anti-inflammatory and antioxidant effects of fish oil and vitamin D supplementation in sickle cell disease patients: a randomized, blinded, placebo-controlled study

Omega-3 and vitamin D supplementation in adults with sickle cell anemia - OVIDA Omega-3 and vitamin D supplementation for sickle cell anemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-10r7d6f3
Enrollment
Unknown
Registered
2021-07-20
Start date
2018-01-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle cell disease

Interventions

Total sample of 120 individuals, matched for gender and age group. Participants will be divided into four groups: Control (30 participants with sickle cell anemia who will receive both vitamin D and f
OD group (30 participants with sickle cell anemia, who will receive fish oil and vitamin D supplementation)
group O- (30 participants with sickle cell anemia who will receive fish oil supplementation and vitamin D placebo)
group D- (30 participants with sickle cell anemia who will receive vitamin D supplementation and fish oil placebo). Supplementation of fish oil will be performed in the amount of 1000 mg per gelatin c
C15.378.071.141
G07.203.300.456

Sponsors

Universidade do Estado do Rio de Janeiro
Lead Sponsor
Ministério da Saúde
Collaborator

Eligibility

Age
19 Years to 59 Years

Inclusion criteria

Inclusion criteria: Adults with ages ranging from 19 to 59 years of age; Be homozygous for sickle cell anemia - HbS (SS genotype); Possibility of attendance at periodic laboratory visits and examinations; Be lucid and oriented.

Exclusion criteria

Exclusion criteria: Participants who have had blood transfusions in the last 1 month before the first evaluation; Participants who present an episode of disease exacerbation at the time of the first evaluation; Participants who have taken vitamin D and / or omega-3 supplementation for less than 6 months or at the time of the first evaluation; Have not been hospitalized for less than fifteen days; People with other types of hemoglobinopathies; Use of Hydroxyurea; Pregnant women.

Design outcomes

Primary

MeasureTime frame
Improvement of the clinical and inflammatory condition. For this, the following parameters will be used: reduction in the number of hospitalizations, reduction in the frequency of pain episodes, reduction in pain intensity, blood count evaluation, lipid profile, C-reactive protein, lactate dehydrogenase, tumor necrosis factor alpha (TNF- a), VCAM, P-selectin, HbS and HbF concentration, indirect oximetry.

Secondary

MeasureTime frame
evaluation of vitamin D levels in patients with sickle cell anemia. Those that are sufficient or deficient according to the measurement of 25 (OH) D will be evaluated, using high performance liquid chromatography coupled with a dioderray detector (HPLC-DAD).;reduction of vaso-occlusive pain crises, through reporting and / or consulting the medical record of the number of hospitalizations before and after supplementation.;improvement of the disposition, through the report of daily activities and tiredness (fatigue) or improvement of the disposition when performing them, before and after the supplementation.;improvement of the hemolytic and vaso-occlusive condition, with evaluation of lactate dehydrogenase and haptoglobin.

Countries

Brazil

Contacts

Public ContactMarta dos Reis

Universidade do Estado do Rio de Janeiro

martacitelli@gmail.com55 21 23340679

Outcome results

None listed

Source: REBEC (via WHO ICTRP)