Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: results of a randomized placebo-controlled clinical trial

Apte, Aditi; Kapoor, Mudra; Naik, Sadanand; Lubree, Himangi; Khamkar, Pooja; Singh, Diksha; Agarwal, Dhiraj; Roy, Sudipto; Kawade, Anand; Juvekar, Sanjay; Banerjee, Rinti; Bavdekar, Ashish

doi:10.1186/s40795-021-00458-8

Table 2 Changes in the hematological and biochemical parameters^a

From: Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: results of a randomized placebo-controlled clinical trial

	LMF oil			Placebo oil			Treatment effect (95% CI)
	N	Value	Adjusted mean change^b	N	Value	Adjusted mean change^b	Treatment effect (95% CI)
Changes in hemoglobin (Hb) levels, gm%
Hb at 6 months	199	10.84 ± 0.88	−0.50	204	10.96 ± 0.90	− 0.54	− 0.01(− 0.26–0.28)
Hb at 12 months	190	10.36 ± 1.26	−0.50	201	10.42 ± 1.30	− 0.54	− 0.01(− 0.26–0.28)
Subgroup of children with no anemia (Hb > 11 g%) at 6 months^e
Hb at 6 months	88	11.61 ± 0.41	−0.70	101	11.68 ± 0.55	− 0.62	−0.08(− 0.38–0.23)
Hb at 12 months	84	10.90 ± 1.03	−0.70	99	11.05 ± 1.09	− 0.62	−0.08(− 0.38–0.23)
Subgroup of children with mild anemia (Hb 10–11 g%) at 6 months^e
Hb at 6 months	85	10.51 ± 0.28	−0.44	77	10.52 ± 0.32	− 0.41	−0.03(− 0.37–0.31)
Hb at 12 months	84	10.08 ± 1.23	−0.44	76	10.08 ± 1.10	− 0.41	−0.03(− 0.37–0.31)
Subgroup of children with moderate anemia(Hb 7- < 10 g%) at 6 months^e
Hb at 6 months	26	9.31 ± 0.56	0.11	26	9.49 ± 0.33	− 0.51	0.62(0.02–1.22)^c
Hb at 12 months	22	9.34 ± 1.26	0.11	26	8.98 ± 1.04	− 0.51	0.62(0.02–1.22)^c
Changes in transferrin saturation (TSAT) levels, %
TSAT at 6 months	199	12.1(7.89–15.9)	−2.36	204	10.9(7.9–15.45)	−2.10	−0.26(−1.89–1.36)
TSAT at 12 months	189	7.9(5.9–13.3)	−2.36	201	8.1(5.8–11.7)	−2.10	−0.26(−1.89–1.36)
Change in 25-Hydroxy vitamin D (25-OH-D) levels, ng/ml
25 OH D at 6 months	199	20.4(13.7–29)	1.46	204	20.85(12–30.05)	−0.18	1.63(− 0.52–3.78)^d
25OH D at 12 months	189	23.7(17.6–30.4)	1.46	201	21.80(16.9–27.9)	−0.18	1.63(− 0.52–3.78)^d

^aValues expressed as Mean+/−SD for parametric data and median (interquartile range) for nonparametric data; ^bParameters adjusted for compliance to the intervention, concomitant administration of iron and vitamin D supplements; ^cp = 0.043, ^d = 0.049; ^e-Subgroup analysis additionally adjusted for gender, weaning age and maternal education, LMF oil Liposomal encapsulated micronutrient fortified oil

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