CTRI Number	CTRI/2017/11/010710 [Registered on: 30/11/2017] Trial Registered Prospectively
Last Modified On:	26/06/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Nutraceutical
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Modification(s)	Evaluation of body oil fortified with iron, folic acid, vitamin B12 and vitamin D for infant massage
Scientific Title of Study Modification(s)	A prospective randomised study to evaluate effect of nano-encapsulated micronutrient fortified body oils for infant massage on developmental and nutritional outcomes
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Ashish Bavdekar  Address  KEM Hospital Research Centre, Rasta Peth, Sardar Moodliar Road, Pune Vadu Rural Health Program Vadu Budruk, Pune Pune MAHARASHTRA 411011 India  Phone     Fax     Email  a.bavdekar@kemhrcpune.org
Details Contact Person Scientific Query Modification(s)	Name  Ashish Bavdekar  Address  KEM Hospital Research Centre, Rasta Peth, Sardar Moodliar Road, Pune Vadu Rural Health Program, Vadu Budruk, Pune Pune MAHARASHTRA 411011 India  Phone     Fax     Email  a.bavdekar@kemhrcpune.org
Details Contact Person Public Query Modification(s)	Name  Ashish Bavdekar  Address  KEM Hospital Research Centre Rasta Peth, Sardar Moodliar Road, Pune Vadu Rural Health Program, Vadu Budruk, Pune Pune MAHARASHTRA 411011 India  Phone     Fax     Email  a.bavdekar@kemhrcpune.org
Source of Monetary or Material Support	Grand Challenges Canada
Primary Sponsor	Name  Grand Challenges Canada  Address  MaRS Centre, West Tower 661 University Avenue, Suite 1720 Toronto, ON M5G 1M1  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Ashish Bavdekar  Vadu Rural Health Program   Shirdi Sai Baba Rural Hospital KEM Hospital Research Centre Village- Vadu Budruk, Taluka Shirur, Pune 412216. Pune   9822056174 bavdekar@vsnl.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  KEM Hospital Research Centre  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Healthy Infants aged 4-6 weeks
Intervention / Comparator Agent	Type  Name  Details  Intervention  Fortified sunflower oil  Sunflower oil fortified with nanoparticles of iron, folic acid, vitamin D and vitamin B12  Comparator Agent  Plain sunflower oil  Plain sunflower oil without nutrients
Inclusion Criteria Modification(s)	Age From  28.00 Day(s) Age To  42.00 Day(s) Gender  Both  Details  1.Healthy infants aged 4-6 weeks with birth weight of at least 2 kg 2.Living within study area for at least next 12 months 3.Parents agreeing to give written informed consent
ExclusionCriteria	Details  1.Babies with generalized skin disorder or skin infection 2.Babies with structural problem affecting more than 5% of their body surface area and likely to result in a defect in epidermal barrier function 3.Severely malnourished: weight for age z-score < -3.0 4.Children with major congenital anomalies 5.Children with major birth or neonatal complications 6.Any other medical condition that in the opinion of investigator may interfere with the subject’s participation in the study
Method of Generating Random Sequence	Stratified block randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Participant and Investigator Blinded
Primary Outcome	Outcome  TimePoints  Change in neurodevelopment evaluated on DASI (Developmental assessment score for Indian Infants) at 1 year of age.   12 months
Secondary Outcome	Outcome  TimePoints  Assessment of local and systemic adverse events   6 months and 12 months   Hb improvement in intervention group as compared to control group   6 months and 12 months   Improvement in 25-OH vitamin D3 levels in intervention group as compared to control group   6 months ad 12 months   Transferrin saturation levels at 6 months and 1 year of age   6 months and 12 months
Target Sample Size	Total Sample Size="444" Sample Size from India="444"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	22/02/2018
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	NA
Brief Summary Modification(s)	Introduction Deficiency of iron and vitamin D in Indian infants is a public health concern and iron deficiency in particular has been associated with poor neurodevelopment. Poor compliance to oral formulation remains a challenge in routine supplement of nutrients. We plan to assess effectiveness of body massage with an innovative oil formulation containing nanosized liposomes of nutrients in prevention of deficiency and improvement of cognitive development. Methods This was a randomized double blind placebo controlled study in 444 healthy infants aged 4-7 weeks who were randomized to receive nano-fortified or placebo oil. The test oil contained liposomes of iron, vitamin B12, folate and vitamin D in amounts not exceeding the required dietary intakes. The oil was gently massaged daily to  infants by the caregivers during first year of life. Outcomes included hemoglobin, vitamin D, transferrin levels at 6 months and 12 months and assessment of neurodevelopmental outcome using developmental assessment of Indian infants (DASII) at 12 months. Results Overall, there was no significant change in the overall hemoglobin levels between the two groups at 12months. However, in the subgroup of moderate anemic children, hemoglobin levels significantly improved [Adjusted mean change of 0.62 gm/dl (95% CI 0.02-1.22); p =0.043]. 25-hydroxy vitamin D levels were marginally improved in the test group at 12 months [Mean 23.7 ng/ml vs. 21.80 ng/ml; p=0.09]. There was no significant effect of the intervention on the overall neurodevelopmental outcome. In the fortified group, participants were rated significantly better for the social interaction cluster in DASII as compared to the placebo group [OR =1.51, 95% CI1.00-2.29, p=0.047]. Conclusion Thus, overall, the intervention of nano-fortified oil marginally improved anemia in moderately anemic children and vitamin D levels but did not have any effect on the neurodevelopmental outcomes. There is scope for further evaluation of similar formulations through mechanistic studies and larger clinical trials in anemic infants.