Vitamin D3 as adjunctive therapy in the treatment of depression in tuberculosis patients: a short-term pilot randomized double-blind controlled study

Figures & data

Figure 1 Flow diagram of patient enrollment.

Table 1 Sociodemographic and clinical data of the groups

Characteristics	Vit D group (n=58)	Control group (n=65)	P-value
Age (years), mean (SD)	38.3 (12.4)	40.2 (11.9)	0.41
Sex: male, n (%)	50 (86.2)	53 (81.5)	0.48
Diabetes mellitus, n (%)	2 (3.4)	3 (4.6)	0.74
Drinking, n (%)	20 (34.5)	20 (30.8)	0.66
Smoking, n (%)	16 (27.6)	21 (32.3)	0.57
Income, n (%)			0.29
Under minimum wage standard	9 (15.5)	15 (23.1)
Over minimum wage standard	49 (84.5)	50 (76.9)
Education, n (%)			0.25
Up to high school	38 (65.5)	36 (55.4)
Beyond high school	20 (34.5)	29 (44.6)
Health insurance modes, n (%)			0.43
Medical insurance	41 (70.7)	50 (76.9)
New rural insurance/urban resident basic medical insurance	17 (29.3)	15 (23.1)
Employed, n (%)	15 (25.9)	23 (35.4)	0.25
Marital status, n (%)			0.12
Not single (married/living together)	48 (82.8)	46 (70.8)
Single (single/widow(er)/divorced/living apart)	10 (17.2)	19 (29.2)
Family history of mood disorders (%)	6 (10.3)	4 (6.1)	0.40
BMI (kg/m^2), mean (SD)	21.2 (3.8)	20.7 (4.1)	0.22
Hemoglobin (g/L), mean (SD)	12.6 (5.4)	12.3 (2.7)	0.26
Plasma corrected calcium (mmol/L)	2.5 (0.3)	2.5 (0.4)	0.47
Plasma Hs-CRP (mg/L), mean (SD)	45.1 (13.3)	37.5 (12.6)	0.31
Plasma albumin (g/L), mean (SD)	33.2 (7.8)	32.7 (4.3)	0.27
Plasma prealbumin (mg/L), mean (SD)	223.6 (37.9)	235.9 (48.1)	0.16
Plasma 25(OH)D (ng/mL), mean (SD)	22.9 (7.1)	24.5 (4.6)	0.39
BDI II scores, mean (SD)	24.6 (13.1)	23.3 (10.5)	0.31
Dietary Vit D intake (IU/d), mean (SD)	147.9 (67.1)	164.3 (58.7)	0.55

Notes: Differences in proportions were tested using Pearson chi-squared test, and differences in mean values were tested using one-way ANOVA or Mann–Whitney test. Each group was compared separately with the placebo group.

Abbreviations: 25(OH)D, 25-hydroxyvitamin D; BDI, Beck Depression Inventory; BMI, body mass index; Hs-CRP, high-sensitivity C-reactive protein; Vit D, vitamin D.

Table 2 Baseline and 8-week values of Vit D and placebo groups

	Vit D group (n=56)			Placebo group (n=64)			P for delta value
	Baseline	8 weeks	Delta*	Baseline	8 weeks	Delta*
Bone metabolism indexes, mean (SD)
Plasma corrected calcium (mmol/L)	2.5 (0.3)	2.5 (0.5)	0.04 (0.01)	2.5 (0.4)	2.5 (0.5)	0.02 (0.02)	0.37
Plasma 25(OH)D (ng/mL)	22.9 (7.1)	27.1 (8.3)	4.2 (2.1)	24.5 (4.6)	23.6 (8.1)	−0.7 (0.5)	0.03
Nutrient indexes, mean (SD)
Plasma albumin (g/L)	33.2 (7.8)	34.1 (5.9)	1.0 (2.2)	32.7 (4.3)	32.3 (6.7)	−0.5 (1.2)	0.23
Plasma prealbumin (mg/L)	223.6 (37.9)	230.4 (41.6)	7.0 (4.7)	235.9 (48.1)	232.1 (36.4)	−6.0 (4.9)	0.35
Inflammatory biomarkers, mean (SD)
Plasma Hs-CRP (mg/L)	45.1 (13.3)	41.2 (22.8)	−4.0 (3.3)	37.5 (12.6)	36.2 (10.8)	−1.3 (1.1)	0.81
Plasma IL-6 (pg/mL)	227.4 (82.3)	202.8 (67.3)	−24.6 (13.4)	259.1 (114.9)	242.6 (89.4)	−16.5 (18.9)	0.053
Plasma TNF-α (pg/mL)	104.9 (35.1)	90.4 (25.6)	−10.0 (7.3)	123.6 (24.8)	115.8 (19.5)	−7.8 (5.3)	0.041
Plasma INF-γ (pg/mL)	87.3 (20.5)	75.4 (16.6)	−12.0 (5.1)	121.4 (55.6)	116.9 (37.1)	−4.5 (3.5)	0.022

Note:

* 8-week score minus score at baseline.

Abbreviations: 25(OH)D, 25-hydroxyvitamin D; Hs-CRP, high-sensitivity C-reactive protein; IL-6, interleukin-6; INF-γ, interferon-γ; TNF-α, tumor necrosis factor-α; Vit D, vitamin D.

Table 3 Association of Vit D3 supplementation with change in mean BDI II score from baseline to 8-week follow-up

	Baseline, mean (SD)	8 weeks, mean (SD)	Delta*,a, mean (SD)	Multivariable-adjusted mean change (95% CI)b	P-value
Vit D group (n=56)	24.6 (13.1)	16.6 (9.4)	−8.0 (3.7)	−1.63 (−2.75 to 0.89)	0.38
Control group (n=64)	23.3 (10.5)	16.9 (8.3)	−6.4 (4.9)	Reference

Notes:

a Positive change reflects a higher BDI II score at 8 weeks vs baseline; negative change reflects a lower BDI II score at 8 weeks vs baseline.

b Multivariable models adjusted for age, time to first negative smear, and 25(OH)D levels.

* Score at 8 weeks minus score at baseline.

Abbreviations: 25(OH)D, 25-hydroxyvitamin D; BDI, Beck Depression Inventory; Vit D, vitamin D.