Sickle Cell Anemia in ChildrenNCT03632876
Nutritional Outcomes After Vitamin A Supplementation in Subjects With SCD
A study testing retinyl palmitate in people with Sickle Cell Anemia in Children and Vitamin A Deficiency in Children, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study establishes the safety and efficacy of vit A supplementation doses (3000 and 6000 IU/d) over 8 weeks in children with SCD-SS, ages 9 and older and test the impact of vit A supplementation on key functional and clinical outcomes. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia in Children, Vitamin A Deficiency in Children
- What is being tested?
- retinyl palmitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2015to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sickle cell disease, SS genotype (subjects with sickle cell disease only)
- Usual state of good health (no hospitalizations, emergency room visits, or unscheduled acute illness clinic visits for two weeks prior to screening)
- Commitment to a 119-day study (subjects with sickle cell disease only), or a 4-day study (healthy volunteers only)
Who cannot join
- Hydroxyurea initiated within the previous 6 weeks (subjects with sickle cell disease only)
- History of stroke (subjects with sickle cell disease only)
- Other chronic conditions that may affect growth, dietary intake or nutritional status
- Retinoic acid (topical or oral), weight loss medication and/or lipid lowering medications
- Subjects with a BMI greater than 98th percentile for age and sex
- Pregnant or lactating females (subjects who become pregnant during the course of the study will not continue participation)
Show all 10Show fewer
- Liver function tests >4 x upper limit of reference range
- Participation in another study with impact on vitamin A status (subjects with sickle cell disease only)
- Use of multi-vitamin or commercial nutritional supplements containing vitamin A (those who are willing to discontinue these supplements, with the approval of the medical care team, will be eligible for the study after a 1 month washout period. Subjects taking nutritional products without vitamin A will be eligible)
- Inability to swallow pills (subjects with sickle cell disease only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
Official title: Vitamin A in Sickle Cell Disease: Improving Sub-optimal Status With Supplementation
This study establishes the safety and efficacy of vit A supplementation doses (3000 and 6000 IU/d) over 8 weeks in children with SCD-SS, ages 9 and older and test the impact of vit A supplementation on key functional and clinical outcomes. Additionally, vitamin A status is assessed in healthy children ages 9 and older to compare to subjects with SCD-SS.
Read the detailed description
Suboptimal vitamin A (vit A) status is prevalent in children with type SS sickle cell disease (SCD-SS) and associated with hospitalizations and poor growth and hematological status. Preliminary data in children with SCD-SS show that vit A supplementation at the dose recommended for healthy children failed to improve vit A status, resulting in no change in hospitalizations, growth or dark adaptation. This indicates an increased vit A requirement most likely due to chronic inflammation, low vit A intake and possible stool or urine loss. The dose of vit A needed to optimize vit A status in subjects with SCD-SS is unknown.
- Being tested
- retinyl palmitate
- Keywords
- Retinol, Stable isotope dilution, DXA, retinyl palmitate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinyl palmitateDietary supplement
The intervention is a daily vitamin A supplement.
| Study group | Role | What they receive |
|---|---|---|
| Lower Dose Vitamin A | Active comparator | Subjects with SCD-SS in the lower dose Vitamin A arm receive 3000IU of retinyl palmitate daily for 8 weeks. Receives: Dietary Supplement: retinyl palmitate |
| Higher Dose Vitamin A | Active comparator | Subjects with SCD-SS in the higher dose Vitamin A arm receive 6000IU of retinyl palmitate daily for 8 weeks. Receives: Dietary Supplement: retinyl palmitate |
| Healthy Comparison Arm | No intervention | Healthy subjects receive no intervention and undergo comparisons to the two vitamin A supplementation arms at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin A status
Serum vitamin A as measured by retinol
Measured: Change from baseline after supplementation for 8 weeks
Secondary outcomes (36)
Vitamin A toxicity
Retinyl palmitate
Measured: Change from baseline after supplementation for 8 weeks
Height Z-score
Measured on a stadiometer, compared to Center for Disease Control (CDC) reference standard to create a z-score
Measured: Change from baseline after supplementation for 8 weeks
Weight Z-score
Measured on a standing scale, compared to CDC reference standard to create a z-score
Measured: Change from baseline after supplementation for 8 weeks
BMI Z-score
Calculated using kg/m^2 and compared to CDC reference standards
Measured: Change from baseline after supplementation for 8 weeks
Fat-free Mass
Calculated from dual-energy x-ray absorptiometry (DEXA) scan
Measured: Change from baseline after supplementation for 8 weeks
Fat-free Mass
Calculated from DEXA scan
Measured: Change from baseline after supplementation for 8 weeks
Fat Mass
Calculated from DEXA scan
Measured: Change from baseline after supplementation for 8 weeks
Upper arm muscle area
Calculated from mid-upper arm circumference
Measured: Change from baseline after supplementation for 8 weeks
Upper arm fat area
Calculated from mid-upper arm circumference and triceps skinfold thickness
Measured: Change from baseline after supplementation for 8 weeks
Muscle strength
Directly measured with Biodex Multi-Joint System 3 Pro
Measured: Change from baseline after supplementation for 8 weeks
Jump strength
Directly measured with Force Plate
Measured: Change from baseline after supplementation for 8 weeks
Upper limb strength
Directly measured with hand-grip strength dynamometer
Measured: Change from baseline after supplementation for 8 weeks
Muscle function
Directly measured with Bruininks-Oseretsky Test of Motor Proficiency
Measured: Change from baseline after supplementation for 8 weeks
Dietary Intake
Analysis of a three-day food record
Measured: Change from baseline after supplementation for 8 weeks
Coefficient of fat absorption
Calculated from 72-hour stool collection and dietary fat intake
Measured: Change from baseline after supplementation for 8 weeks
Hemoglobin
Direct measurement through spectral absorption
Measured: Change from baseline after supplementation for 8 weeks
Hematocrit
Direct measurement through spectral absorption
Measured: Change from baseline after supplementation for 8 weeks
Fetal hemoglobin
Direct measurement through quantitative flow cytometry
Measured: Change from baseline after supplementation for 8 weeks
Mean corpuscular volume
Direct measurement through quantitative flow cytometry
Measured: Change from baseline after supplementation for 8 weeks
Mean corpuscular hemoglobin
Calculated from hemoglobin mass and erythrocyte count
Measured: Change from baseline after supplementation for 8 weeks
Mean corpuscular hemoglobin concentration
Calculated from hemoglobin divided by hematocrit
Measured: Change from baseline after supplementation for 8 weeks
Reticulocyte count
Direct measurement through quantitative flow cytometry
Measured: Change from baseline after supplementation for 8 weeks
Retinol binding protein, serum
Direct measurement through quantitative nephelometry
Measured: Change from baseline after supplementation for 8 weeks
Retinol binding protein, urine
Direct measurement through quantitative nephelometry
Measured: Change from baseline after supplementation for 8 weeks
Urine creatinine
Direct measurement through quantitative spectrophotometry
Measured: Change from baseline after supplementation for 8 weeks
Serum creatinine
Direct measurement through quantitative spectrophotometry
Measured: Change from baseline after supplementation for 8 weeks
Serum alanine aminotransferase
Direct measurement through quantitative enzymatic assay
Measured: Change from baseline after supplementation for 8 weeks
Serum aspartate aminotransferase
Direct measurement through quantitative enzymatic assay
Measured: Change from baseline after supplementation for 8 weeks
Serum gamma glutamyltransferase
Direct measurement through quantitative enzymatic assay
Measured: Change from baseline after supplementation for 8 weeks
Serum alkaline phosphatase
Direct measurement through quantitative enzymatic assay
Measured: Change from baseline after supplementation for 8 weeks
Serum bilirubin
Direct measurement through quantitative quantitative spectrophotometry
Measured: Change from baseline after supplementation for 8 weeks
High-sensitivity c-reactive protein
Direct measurement through quantitative quantitative immunoturbidimetry
Measured: Change from baseline after supplementation for 8 weeks
Tumor necrosis factor alpha
Direct measurement through quantitative quantitative multiplex bead assay
Measured: Change from baseline after supplementation for 8 weeks
White blood cell count
Direct measurement through automated cell count
Measured: Change from baseline after supplementation for 8 weeks
White blood cell differential
Direct measurement through automated cell count
Measured: Change from baseline after supplementation for 8 weeks
Lymphocyte subtypes
Direct measurement through quantitative flow cytometry
Measured: Change from baseline after supplementation for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start2 Oct 2015
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell Anemia in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in parallel groups will be randomized to one of two doses of vitamin A supplementation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Virginia Stallings, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632876
- Sponsor's protocol ID
- 13-010081
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be shared upon request, after deidentification.
Publications
Ribaya-Mercado JD, Maramag CC, Tengco LW, Dolnikowski GG, Blumberg JB, Solon FS. Carotene-rich plant foods ingested with minimal dietary fat enhance the total-body vitamin A pool size in Filipino schoolchildren as assessed by stable-isotope-dilution methodology. Am J Clin Nutr. 2007 Apr;85(4):1041-9. doi: 10.1093/ajcn/85.4.1041.
PubMed 17413103Solomons NW. Vitamin A. In: B.Bowman, R.Russell, editors. Present Knowledge in Nutrition, Volume I. 9 ed. Washington DC: International Life Science Institute Press; 2006:157-183
Ross CA. Vitamin A and carotenoids. In: M.E.Shils, M.Shike, C.A.Ross, B.Caballero, R.J.Cousins, editors. Modern Nutrition in Health and Disease. 10 ed. Philadelphia: Lippincott, Williams and Wilkins; 2006:351-375
Schall JI, Zemel BS, Kawchak DA, Ohene-Frempong K, Stallings VA. Vitamin A status, hospitalizations, and other outcomes in young children with sickle cell disease. J Pediatr. 2004 Jul;145(1):99-106. doi: 10.1016/j.jpeds.2004.03.051.
PubMed 15238915Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.
PubMed 11269606Dougherty KA, Schall JI, Kawchak DA, Green MH, Ohene-Frempong K, Zemel BS, Stallings VA. No improvement in suboptimal vitamin A status with a randomized, double-blind, placebo-controlled trial of vitamin A supplementation in children with sickle cell disease. Am J Clin Nutr. 2012 Oct;96(4):932-40. doi: 10.3945/ajcn.112.035725. Epub 2012 Sep 5.
PubMed 22952182Haskell MJ, Handelman GJ, Peerson JM, Jones AD, Rabbi MA, Awal MA, Wahed MA, Mahalanabis D, Brown KH. Assessment of vitamin A status by the deuterated-retinol-dilution technique and comparison with hepatic vitamin A concentration in Bangladeshi surgical patients. Am J Clin Nutr. 1997 Jul;66(1):67-74. doi: 10.1093/ajcn/66.1.67.
PubMed 9209171Ribaya-Mercado JD, Solon FS, Solon MA, Cabal-Barza MA, Perfecto CS, Tang G, Solon JA, Fjeld CR, Russell RM. Bioconversion of plant carotenoids to vitamin A in Filipino school-aged children varies inversely with vitamin A status. Am J Clin Nutr. 2000 Aug;72(2):455-65. doi: 10.1093/ajcn/72.2.455.
PubMed 10919941Olson JA. Serum levels of vitamin A and carotenoids as reflectors of nutritional status. J Natl Cancer Inst. 1984 Dec;73(6):1439-44.
PubMed 6439934Kawchak DA, Schall JI, Zemel BS, Ohene-Frempong K, Stallings VA. Adequacy of dietary intake declines with age in children with sickle cell disease. J Am Diet Assoc. 2007 May;107(5):843-8. doi: 10.1016/j.jada.2007.02.015.
PubMed 17467383Garcia OP. Effect of vitamin A deficiency on the immune response in obesity. Proc Nutr Soc. 2012 May;71(2):290-7. doi: 10.1017/S0029665112000079. Epub 2012 Feb 28.
PubMed 22369848Cantorna MT, Nashold FE, Hayes CE. In vitamin A deficiency multiple mechanisms establish a regulatory T helper cell imbalance with excess Th1 and insufficient Th2 function. J Immunol. 1994 Feb 15;152(4):1515-22.
PubMed 8120366Esteban-Pretel G, Marin MP, Cabezuelo F, Moreno V, Renau-Piqueras J, Timoneda J, Barber T. Vitamin A deficiency increases protein catabolism and induces urea cycle enzymes in rats. J Nutr. 2010 Apr;140(4):792-8. doi: 10.3945/jn.109.119388. Epub 2010 Feb 24.
PubMed 20181784Kennedy KA, Porter T, Mehta V, Ryan SD, Price F, Peshdary V, Karamboulas C, Savage J, Drysdale TA, Li SC, Bennett SA, Skerjanc IS. Retinoic acid enhances skeletal muscle progenitor formation and bypasses inhibition by bone morphogenetic protein 4 but not dominant negative beta-catenin. BMC Biol. 2009 Oct 8;7:67. doi: 10.1186/1741-7007-7-67.
PubMed 19814781Dougherty KA, Schall JI, Rovner AJ, Stallings VA, Zemel BS. Attenuated maximal muscle strength and peak power in children with sickle cell disease. J Pediatr Hematol Oncol. 2011 Mar;33(2):93-7. doi: 10.1097/MPH.0b013e318200ef49.
PubMed 21228717
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A in Sickle Cell Disease: Improving Sub-optimal Status With Supplementation
- ClinicalTrials.gov ID
- NCT03632876
- Acronym / sponsor ID
- 13-010081
- Keywords
- Retinol, Stable isotope dilution, DXA, retinyl palmitate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Penn State University, Newcastle University
- Study start
- 2 Oct 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study establishes the safety and efficacy of vit A supplementation doses (3000 and 6000 IU/d) over 8 weeks in children with SCD-SS, ages 9 and older and test the impact of vit A supplementation on key functional and clinical outcomes. Additionally, vitamin A status is assessed in healthy children ages 9 and older to compare to subjects with SCD-SS.
Detailed description
Suboptimal vitamin A (vit A) status is prevalent in children with type SS sickle cell disease (SCD-SS) and associated with hospitalizations and poor growth and hematological status. Preliminary data in children with SCD-SS show that vit A supplementation at the dose recommended for healthy children failed to improve vit A status, resulting in no change in hospitalizations, growth or dark adaptation. This indicates an increased vit A requirement most likely due to chronic inflammation, low vit A intake and possible stool or urine loss. The dose of vit A needed to optimize vit A status in subjects with SCD-SS is unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects in parallel groups will be randomized to one of two doses of vitamin A supplementation.
| Arm | Type | Receives |
|---|---|---|
| Lower Dose Vitamin A | Active comparator | Dietary Supplement: retinyl palmitateSubjects with SCD-SS in the lower dose Vitamin A arm receive 3000IU of retinyl palmitate daily for 8 weeks. |
| Higher Dose Vitamin A | Active comparator | Dietary Supplement: retinyl palmitateSubjects with SCD-SS in the higher dose Vitamin A arm receive 6000IU of retinyl palmitate daily for 8 weeks. |
| Healthy Comparison Arm | No intervention | –Healthy subjects receive no intervention and undergo comparisons to the two vitamin A supplementation arms at baseline. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Sickle cell disease, SS genotype (subjects with sickle cell disease only)
- Usual state of good health (no hospitalizations, emergency room visits, or unscheduled acute illness clinic visits for two weeks prior to screening)
- Commitment to a 119-day study (subjects with sickle cell disease only), or a 4-day study (healthy volunteers only)
Key exclusion criteria (10 listed)
- Hydroxyurea initiated within the previous 6 weeks (subjects with sickle cell disease only)
- History of stroke (subjects with sickle cell disease only)
- Other chronic conditions that may affect growth, dietary intake or nutritional status
- Retinoic acid (topical or oral), weight loss medication and/or lipid lowering medications
- Subjects with a BMI greater than 98th percentile for age and sex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retinyl palmitateThe intervention is a daily vitamin A supplement. | Dietary supplement | Higher Dose Vitamin A, Lower Dose Vitamin A |
Primary outcome
Serum Vitamin A status
Time frame: Change from baseline after supplementation for 8 weeks
Serum vitamin A as measured by retinol
36 secondary outcomes
Vitamin A toxicity
Time frame: Change from baseline after supplementation for 8 weeks
Height Z-score
Time frame: Change from baseline after supplementation for 8 weeks
Weight Z-score
Time frame: Change from baseline after supplementation for 8 weeks
BMI Z-score
Time frame: Change from baseline after supplementation for 8 weeks
Fat-free Mass
Time frame: Change from baseline after supplementation for 8 weeks
Fat-free Mass
Time frame: Change from baseline after supplementation for 8 weeks
Fat Mass
Time frame: Change from baseline after supplementation for 8 weeks
Upper arm muscle area
Time frame: Change from baseline after supplementation for 8 weeks
Upper arm fat area
Time frame: Change from baseline after supplementation for 8 weeks
Muscle strength
Time frame: Change from baseline after supplementation for 8 weeks
Jump strength
Time frame: Change from baseline after supplementation for 8 weeks
Upper limb strength
Time frame: Change from baseline after supplementation for 8 weeks
Muscle function
Time frame: Change from baseline after supplementation for 8 weeks
Dietary Intake
Time frame: Change from baseline after supplementation for 8 weeks
Coefficient of fat absorption
Time frame: Change from baseline after supplementation for 8 weeks
Hemoglobin
Time frame: Change from baseline after supplementation for 8 weeks
Hematocrit
Time frame: Change from baseline after supplementation for 8 weeks
Fetal hemoglobin
Time frame: Change from baseline after supplementation for 8 weeks
Mean corpuscular volume
Time frame: Change from baseline after supplementation for 8 weeks
Mean corpuscular hemoglobin
Time frame: Change from baseline after supplementation for 8 weeks
Mean corpuscular hemoglobin concentration
Time frame: Change from baseline after supplementation for 8 weeks
Reticulocyte count
Time frame: Change from baseline after supplementation for 8 weeks
Retinol binding protein, serum
Time frame: Change from baseline after supplementation for 8 weeks
Retinol binding protein, urine
Time frame: Change from baseline after supplementation for 8 weeks
Urine creatinine
Time frame: Change from baseline after supplementation for 8 weeks
Serum creatinine
Time frame: Change from baseline after supplementation for 8 weeks
Serum alanine aminotransferase
Time frame: Change from baseline after supplementation for 8 weeks
Serum aspartate aminotransferase
Time frame: Change from baseline after supplementation for 8 weeks
Serum gamma glutamyltransferase
Time frame: Change from baseline after supplementation for 8 weeks
Serum alkaline phosphatase
Time frame: Change from baseline after supplementation for 8 weeks
Serum bilirubin
Time frame: Change from baseline after supplementation for 8 weeks
High-sensitivity c-reactive protein
Time frame: Change from baseline after supplementation for 8 weeks
Tumor necrosis factor alpha
Time frame: Change from baseline after supplementation for 8 weeks
White blood cell count
Time frame: Change from baseline after supplementation for 8 weeks
White blood cell differential
Time frame: Change from baseline after supplementation for 8 weeks
Lymphocyte subtypes
Time frame: Change from baseline after supplementation for 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 17413103Ribaya-Mercado JD, Maramag CC, Tengco LW, Dolnikowski GG, Blumberg JB, Solon FS. Carotene-rich plant foods ingested with minimal dietary fat enhance the total-body vitamin A pool size in Filipino schoolchildren as assessed by stable-isotope-dilution methodology. Am J Clin Nutr. 2007 Apr;85(4):1041-9. doi: 10.1093/ajcn/85.4.1041.
- BackgroundSolomons NW. Vitamin A. In: B.Bowman, R.Russell, editors. Present Knowledge in Nutrition, Volume I. 9 ed. Washington DC: International Life Science Institute Press; 2006:157-183
- BackgroundRoss CA. Vitamin A and carotenoids. In: M.E.Shils, M.Shike, C.A.Ross, B.Caballero, R.J.Cousins, editors. Modern Nutrition in Health and Disease. 10 ed. Philadelphia: Lippincott, Williams and Wilkins; 2006:351-375
- Background: PubMed 15238915Schall JI, Zemel BS, Kawchak DA, Ohene-Frempong K, Stallings VA. Vitamin A status, hospitalizations, and other outcomes in young children with sickle cell disease. J Pediatr. 2004 Jul;145(1):99-106. doi: 10.1016/j.jpeds.2004.03.051.
- Background: PubMed 11269606Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.
- Background: PubMed 22952182Dougherty KA, Schall JI, Kawchak DA, Green MH, Ohene-Frempong K, Zemel BS, Stallings VA. No improvement in suboptimal vitamin A status with a randomized, double-blind, placebo-controlled trial of vitamin A supplementation in children with sickle cell disease. Am J Clin Nutr. 2012 Oct;96(4):932-40. doi: 10.3945/ajcn.112.035725. Epub 2012 Sep 5.
- Background: PubMed 9209171Haskell MJ, Handelman GJ, Peerson JM, Jones AD, Rabbi MA, Awal MA, Wahed MA, Mahalanabis D, Brown KH. Assessment of vitamin A status by the deuterated-retinol-dilution technique and comparison with hepatic vitamin A concentration in Bangladeshi surgical patients. Am J Clin Nutr. 1997 Jul;66(1):67-74. doi: 10.1093/ajcn/66.1.67.
- Background: PubMed 10919941Ribaya-Mercado JD, Solon FS, Solon MA, Cabal-Barza MA, Perfecto CS, Tang G, Solon JA, Fjeld CR, Russell RM. Bioconversion of plant carotenoids to vitamin A in Filipino school-aged children varies inversely with vitamin A status. Am J Clin Nutr. 2000 Aug;72(2):455-65. doi: 10.1093/ajcn/72.2.455.
- Background: PubMed 6439934Olson JA. Serum levels of vitamin A and carotenoids as reflectors of nutritional status. J Natl Cancer Inst. 1984 Dec;73(6):1439-44.
- Background: PubMed 17467383Kawchak DA, Schall JI, Zemel BS, Ohene-Frempong K, Stallings VA. Adequacy of dietary intake declines with age in children with sickle cell disease. J Am Diet Assoc. 2007 May;107(5):843-8. doi: 10.1016/j.jada.2007.02.015.
- Background: PubMed 22369848Garcia OP. Effect of vitamin A deficiency on the immune response in obesity. Proc Nutr Soc. 2012 May;71(2):290-7. doi: 10.1017/S0029665112000079. Epub 2012 Feb 28.
- Background: PubMed 8120366Cantorna MT, Nashold FE, Hayes CE. In vitamin A deficiency multiple mechanisms establish a regulatory T helper cell imbalance with excess Th1 and insufficient Th2 function. J Immunol. 1994 Feb 15;152(4):1515-22.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be shared upon request, after deidentification.
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Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Stallings, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retinyl palmitate in people with Sickle Cell Anemia in Children and Vitamin A Deficiency in Children, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Vitamin A status (time frame: Change from baseline after supplementation for 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632876, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.