Evaluation of bodyoil fortified with iron, folic acid, vitamin B12 and vitamin D for infant massage

Completed

Conditions: Healthy Infants aged 4-6 weeks

Registration Number: CTRI/2017/11/010710

Lead Sponsor: Grand Challenges Canada

Brief Summary: **Introduction**

Deficiency of iron andvitamin D in Indian infants is a public health concern and iron deficiency inparticular has been associated with poor neurodevelopment. Poor compliance tooral formulation remains a challenge in routine supplement of nutrients. Weplan to assess effectiveness of body massage with an innovative oil formulationcontaining nanosized liposomes of nutrients in prevention of deficiency and improvementof cognitive development.

**Methods**

Thiswas a randomized double blind placebo controlled study in 444 healthy infantsaged 4-7 weeks who were randomized to receive nano-fortified or placebo oil. Thetest oil contained liposomes of iron, vitamin B12, folate and vitamin D inamounts not exceeding the required dietary intakes. The oil was gently massageddaily to infants by the caregiversduring first year of life. Outcomes included hemoglobin, vitamin D, transferrinlevels at 6 months and 12 months and assessment of neurodevelopmental outcomeusing developmental assessment of Indian infants (DASII) at 12 months.

**Results**

Overall,there was no significant change in the overall hemoglobin levels between thetwo groups at 12months. However, in the subgroup of moderate anemic children, hemoglobinlevels 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 testgroup at 12 months [Mean 23.7 ng/ml vs. 21.80 ng/ml; p=0.09]. There was no significanteffect of the intervention on the overall neurodevelopmental outcome. Inthe fortified group, participants were rated significantly better for thesocial 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 moderatelyanemic children and vitamin D levels but did not have any effect on theneurodevelopmental outcomes. There is scope for further evaluation of similarformulations through mechanistic studies and larger clinical trials in anemicinfants.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 444

Inclusion Criteria

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.

Exclusion Criteria

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 subjectâ€™s participation in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in neurodevelopment evaluated on DASI (Developmental assessment score for Indian Infants) at 1 year of age.	12 months

Secondary Outcome Measures

Name	Time	Method
Transferrin saturation levels at 6 months and 1 year of age
Hb improvement in intervention group as compared to control group
Improvement in 25-OH vitamin D3 levels in intervention group as compared to control group
Assessment of local and systemic adverse events	6 months and 12 months

Trial Locations

Locations (1): Vadu Rural Health Program
🇮🇳
Pune, MAHARASHTRA, India
Vadu Rural Health Program
🇮🇳Pune, MAHARASHTRA, India
Ashish Bavdekar
Principal investigator
9822056174
bavdekar@vsnl.com