Effects of a Single Oral Megadose of Vitamin D3 on Inflammation and Oxidative Stress Markers in Overweight and Obese Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Figures & data

Figure 1 Double-blind, controlled trial flow chart. *One woman with normal weight was removed of trial. **Men were not included in the study.

Table 1 Characteristics of the Sample at the Beginning of the Study

Variables	VD3		Placebo		Total		P-value
	n	%	n	%	n	%
Age
Less than or equal to 45 years	8	50.0	8	50.0	16	100	0.837*
More than 45 years	6	46.2	7	50.0	13	100
Skin phototype
Phototypes: I, II, III, IV	12	44.4	15	55.6	27	100	0.224^#
Phototype V	2	100	0	0.0	2	100
Time of exposure to sunlight
Less than or equal to 15 minutes	10	52.6	9	47.4	19	100	0.700^#
More than 15 minutes	4	40.0	6	60.0	10	100
Use of sunscreen
No	5	50.0	5	50.0	10	100	0.893*
Yes	9	47.4	10	52.6	19	100
Use of sunscreen
Daily	1	14.3	6	85.7	7	100	0.081^#
When being exposed to sunlight	5	71.4	2	28.6	7	100
Other	3	60.0	2	40.0	5	100
Does not use	5	50.0	5	50.0	10	100
Physical activity
No	12	50.0	12	50.0	24	100	1.000^#
Yes	2	40.0	3	60.0	5	100
Physical activity with exposure to sunlight
No	13	50.0	13	50.0	26	100	1.000^#
Yes	1	33.3	2	66.7	3	100
Nutritional status
Overweight	6	66.7	3	33.3	9	100	0.177^#
Obese	8	40.0	12	60.0	20	100

Notes: *Chi-square test; ^#Fisher’s exact test; p-value shows a non-significant difference (p>0.05).

Table 2 Anthropometric Characteristics Among Women Receiving a Single Oral Megadose of VD3 Supplementation (n=14) or a Placebo (n=15) Before and After 4-Week Intervention

Variables	Placebo	VD3	p-value
WC (cm)
Before	93.7 (88.2–99.1)	88.6 (83.1–94.1)	0.171
Week 4	95.0 (89.0–101.1)	88.9 (83.9–93.4)	0.106
WHR
Before	0.84 (0.79–0.90)	0.81 (0.77–0.84)	0.248
Week 4	0.85 (0.80–0.89)	0.81 (0.78–0.85)	0.263
WHtR
Before	0.59 (0.55–0.63)	0.56 (0.52–0.59)	0.138
Week 4	0.60 (0.56–0.64)	0.56 (0.53–0.59)	0.070
BMI (kg/m^2)
Before	33.3 (30.6–35.9)	30.8 (27.9–33.7)	0.179
Week 4	33.4 (30.7–36.1)	30.7 (27.8–33.4)	0.133

Abbreviations: WC, waist circumference; WHR, waist-hip ratio; WHtR, waist-height ratio; BMI, body mass index.

Table 3 Biochemical Variables Among Women Receiving a Single Oral Megadose of VD3 Supplementation (n=14) or the Placebo (n=15) in the Moments Before and After 4-Week Intervention

Variables	Placebo	VD3	p-value
Calcium (mg/dL)
Before	9.0 (8.8–9.2)	8.9 (8.7–9.1)	0.715
Week 4	9.5 (9.3–9.7)*	9.4 (9.2–9.6)*	0.506
PTH (pg/mL)
Before	43.9 (29.7–78.9)	43.9 (35.2–52.6)	0.898
Week 4	54.8 (45.2–64.4)*	42.4 (16.7–90.6)	0.049
AST (IU/L)
Before	21.5 (18.2–24.7)	21.6 (19.0–24.1)	0.957
Week 4	18.9 (12.0–48.0)	16.1 (14.2–18.1)*	0.441
ALT (IU/L)#
Before	25.0 (16.0–42.0)	19.5 (11.0–46.0)	0.099
Week 4	24.0 (12.0–72.0)	16.0 (11.0–31.0)*	0.013
Creatinine (mg/dL)
Before	0.82 (0.75–0.89)	0.79 (0.73–0.85)	0.465
Week 4	0.64 (0.59–0.69)*	0.69 (0.64–0.74)*	0.179
FG (mg/dL)^#
Before	95 (82–157)	89.5 (77–179)	0.690
Week 4	96 (89–170)	94 (83–167)	0.370

Notes: *p-value shows a significant difference between moments (p<0.05). ^#Non-parametric data

Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase; FG, fasting glucose. PTH, parathyroid hormone.

Figure 2 Effects of a single oral megadose of VD3 supplementation on 25 hydroxy-vitamin D and oxidative stress and inflammation variables in overweight and obese women with insufficiency or deficiency of vitamin D. Assessment of the serum levels of hydroxy-vitamin D (A), total antioxidant capacity (B), malondialdehyde (C), high-sensitivity C-reactive protein (D) and alpha glycoprotein (E) in overweight and obese women with insufficiency or deficiency of vitamin D who received a single oral megadose of VD3. Baseline and intervention data were compared by paired t-tests or the Wilcoxon rank-sum test according to the data distribution.