FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/11/029135 [Registered on: 16/11/2020] Trial Registered Prospectively
Last Modified On: 11/11/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Experimental/Bioavailability study 
Study Design  Other 
Public Title of Study   Beta carotene absorption and vitamin A status in humans 
Scientific Title of Study   Measuring beta-carotene bioavailability, bioconversion and vitamin A status in humans. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anura V Kurpad 
Designation  Professor 
Affiliation  St. Johns Medical College 
Address  Department of Physiology and Nutrition (3rd floor-old wing) St. Johns Medical college, Sarjapur Road, Koramangala, Bangalore
Department of Physiology and Nutrition (3rd floor-old wing) St. Johns Medical college, Sarjapur Road, Koramangala, Bangalore-560034
Bangalore
KARNATAKA
560034
India 
Phone  9686512233  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarita Devi 
Designation  Lecturer 
Affiliation  St. Johns Research Institute 
Address  Department of Physiology and Nutrition (3rd floor-old wing) St. Johns Medical College and Research Institute, Sarjapur Road, Koramangala, Bangalore
Department of Physiology and Nutrition (3rd floor-old wing) St. Johns Medical college and Research Institute, Sarjapur Road, Koramangala, Bangalore-560034
Bangalore
KARNATAKA
560034
India 
Phone  09986426938  
Fax    
Email  sarita@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Sarita Devi 
Designation  Lecturer 
Affiliation  St. Johns Research Institute 
Address  Department of Physiology and Nutrition (3rd floor-old wing) St. Johns Medical college and Research Institute, Sarjapur Road, Koramangala, Bangalore
Department of Physiology and Nutrition (3rd floor-old wing) St. Johns Medical college and Research Institute, Sarjapur Road, Koramangala, Bangalore-560034
Bangalore
KARNATAKA
560034
India 
Phone  09986426938  
Fax    
Email  sarita@sjri.res.in  
 
Source of Monetary or Material Support  
St. Johns Research Institute, Koramangala, Bangalore-560034 
 
Primary Sponsor  
Name  Department of Biotechnology Government of India India Alliance  
Address  DBT/Wellcome Trust India Alliance, Nishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad - 500034 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarita Devi  St. Johns Medical College  Division of Nutrition, 3rd floor (old wing), Sarjapur Road, Koramangala, Bangalore 560034
Bangalore
KARNATAKA 		 09986426938

sarita@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and females with no chronic and acute illness for the last 3 months and with normal blood biochemistry 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stable isotope labelled Beta carotene and Retinyl acetate  Dual isotopic dose of 13C10 beta- Carotene (2mg/ml) and D4 Retinyl acetate dose (1mg/ml)in sunflower oil will be given on the study day to participants along with a standardised meal. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Six healthy male and females with no chronic and acute illness for the last 3 months and with normal blood biochemistry. 
 
ExclusionCriteria 
Details  Those who are pregnant, smoking, or with high blood pressure, diabetes and with BMI greater than 30 kg/m2 or with liver/kidney/gastrointestinal disease, lipid metabolic disorders, and consuming multivitamin (containing vitamins A, C, E) or beta -carotene supplements 3 months prior to the study start.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Beta carotene bioconversion efficiency  One time measurement with biospecimen collection at day 0, 1, 2, 7 and 14  
 
Secondary Outcome  
Outcome  TimePoints 
vitamin A status   Baseline 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/11/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Introduction: Vitamin A is an important micronutrient and populations at risk of Vitamin A deficiency (VAD) includes pregnant and lactating women and school children (1). VAD is usually assessed by serum retinol, a qualitative indicator which is the most common biochemical parameter but it is homeostatically controlled until liver reserves become exteremely low. Recent data from our country using these indicators suggests that although clinical deficiency has declined, marginal vitamin A status may still be prevalent and difficult to diagnose (2). In addition, the effect of sub clinical vitamin A deficiency on human health and the appropriate way to manage it is unknown. The dominant strategy used for the elimination and prevention of vitamin A deficiency has been the use of high dose vitamin A capsules through supplementation programmes. Since Vitamin A overdosing is potentially possible with pre-formed Vitamin A, it does not happen when carotene is ingested. A good source of carotene is green leafy vegetables (GLV), and therefore, using an increased intake of GLV is also a worthwhile method to increase Vitamin A status (stores) in the body. However, when subjects are fed with GLV, it is thought that the carotene is converted into Vitamin A in the body with an efficiency ratio of 12:1 or 8:1 (that is, 8 moles of carotene convert to 1 mole of retinol) (3-7). However, this is not known with accuracy, and the efficiency may vary with nutritional status and source of carotene. Therefore, it is important to measure the beta-carotene bioavailability, bioconversion and vitamin A status in humans accurately before the Vitamin A stores can be measured. 
Justification / need for the study: Increasing the intake of carotenoids, primarily through beta -carotene, is considered to be a safe way of restoring the vitamin A reserves of an individual because high doses of preformed vitamin A have adverse health effects (3). Since the current vitamin A equivalency ratio for beta -carotene is varying and have large inter-individual variations in both absorption and conversion (4–8), there is a need for quantifying the bioconversion efficiency in targeted population before measuring the their Vitamin A stores.
References:
  1. Wolf, G. Multiple functions of vitamin A. Physiol. Rev 1984. 64: 873–938.
  2. World Health Organization (WHO). Global prevalence of vitamin A deficiency in populations at risk 1995-2005. WHO Global Database on Vitamin A Deficiency. Geneva: WHO; 2009.
  3. Tang , G. 2010 . Bioconversion of dietary provitamin A carotenoids to vitamin A in humans. Am. J. Clin. Nutr. 91 : 1468S – 1473S .
  4. Borel , P. , P. Grolier , N. Mekki , Y. Boirie , Y. Rochette , B. Le Roy , M. C. Alexandre-Gouabau , D. Lairon , and V. Azais-Braesco .1998 . Low and high responders to pharmacological doses of beta-carotene: proportion in the population, mechanisms involved and consequences on beta-carotene metabolism. J. Lipid Res. 39 :2250 – 2260 .
  5. Hickenbottom , S. J. , J. R. Follett , Y. M. Lin , S. R. Dueker , B. J. Burri ,T. R. Neidlinger , and A. J. Clifford . 2002 . Variability in conversion of beta-carotene to vitamin A in men as measured by using a double-tracer study design. Am. J. Clin. Nutr. 75 : 900 – 907 .
  6. Leung , W. C. , S. Hessel , C. Meplan , J. Flint , V. Oberhauser , F. Tourniaire , J. E. Hesketh , J. von Lintig , and G. Lietz . 2009 . Two common single nucleotide polymorphisms in the gene encoding beta-carotene 15,15 ′ -monoxygenase alter beta-carotene metabolism in female volunteers. FASEB J. 23 : 1041 – 1053 .
  7. Lietz , G. , A. Oxley , W. Leung , and J. Hesketh . 2012 . Single nucleotide polymorphisms upstream from the beta -carotene 15,15 ′ -monoxygenase gene influence provitamin A conversion efficiency in female volunteers. J. Nutr. 142 : 161S – 165S .
  8. Sabrina J Hickenbottom, Jennifer R Follett, Yumei Lin, Stephen R Dueker, Betty J Burri, Terry R Neidlinger, Andrew J Clifford, Variability in conversion of β-carotene to vitamin A in men as measured by using a double-tracer study design, The American Journal of Clinical Nutrition, Volume 75, Issue 5, May 2002, Pages 900–907, https://doi.org/10.1093/ajcn/75.5.900

 
Close