Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Menstrual Cycle Abnormalities, Hormonal Profile, and IGF-1 System in Polycystic Ovary Syndrome Patients: A Randomized, Placebo-Controlled Clinical Trial
Table 2
Clinical and hormonal parameters of study subjects in both groups before and after 8 weeks of intervention.
Metformin + placebo ()
value
Metformin + calcium + vitamin D3 ()
value
value#
value‡
Before
After
Mean change
Before
After
Mean change
Weight (kg)
71.39 ± 14.79
70.48 ± 15.19
−0.91 ± 1.67
0.047
64.29 ± 13.02
62.54 ± 13.10
−1.76 ± 2.23
0.004
0.147
0.223
BMI (kg/m2)
28.01 ± 4.41
27.63 ± 4.35
−0.39 ± 0.66
0.032
25.48 ± 4.97
24.78 ± 4.99
−0.70 ± 0.90
0.004
0.128
0.255
Waist circumference (cm)
90.88 ± 12.66
88.75 ± 13.53
−2.13 ± 2.09
0.007
84.61 ± 10.43
81.58 ± 10.31
−3.03 ± 3.12
0.003
0.124
0.135
Hip circumference (cm)
106.25 ± 9.12
104.94 ± 9.28
−1.31 ± 1.35
0.001
103.50 ± 10.46
101.28 ± 10.57
−2.22 ± 2.13
0.0001
0.423
0.153
Waist/hip
0.85 ± 0.06
0.84 ± 0.07
−0.01 ± 0.02
0.026
0.82 ± 0.04
0.80 ± 0.04
−0.01 ± 0.03
0.039
0.088
0.825
LH (mIU/ml)
10.03 ± 5.55
6.86 ± 3.76
−3.17 ± 5.20
0.028
7.73 ± 5.17
6.10 ± 3.23
−1.63 ± 3.04
0.149
0.144
0.403
FSH (mIU/ml)
6.33 ± 2.10
6.89 ± 1.91
0.56 ± 1.16
0.073
5.45 ± 1.73
6.17 ± 1.67
0.72 ± 1.36
0.037
0.187
0.707
LH/FSH
1.77 ± 1.26
1.02 ± 0.48
−0.74 ± 1.22
0.027
1.45 ± 0.94
1.04 ± 0.68
−0.41 ± 0.51
0.003
0.506
0.721
IGF-1 (ng/ml)
193.61 ± 90.25
184.33 ± 72.39
−9.28 ± 93.01
0.695
208.56 ± 106.52
180.35 ± 86.72
−28.21 ± 46.33
0.019
0.664
0.450
IGFBP-1 (ng/ml)
5.59 ± 5.47
4.71 ± 3.30
−0.88 ± 5.48
0.918
7.42 ± 6.14
7.50 ± 8.73
0.08 ± 6.32
0.879
0.368
0.959
IGF-1/IGFBP-1
89.69 ± 123.30
91.02 ± 126.77
1.33 ± 84.84
0.951
76.01 ± 104.57
43.61 ± 37.54
−32.40 ± 74.49
0.231
0.463
0.670
Vitamin D (ng/ml)
19.88 ± 3.92
19.99 ± 5.78
0.11 ± 4.79
0.928
20.42 ± 6.10
39.80 ± 5.55
19.38 ± 7.78
0.0001
0.764
0.0001
Calcium (mg/dl)
9.40 ± 0.71
9.41 ± 0.66
0.01 ± 0.86
0.977
9.09 ± 0.43
9.92 ± 0.84
0.83 ± 0.82
0.0001
0.126
0.014
Phosphorus (mg/dl)
3.82 ± 0.83
4.08 ± 1.51
0.26 ± 1.78
0.875
3.56 ± 0.72
3.94 ± 0.50
0.38 ± 0.85
0.072
0.330
0.281
BMI: body mass index; LH: luteinizing hormone; FSH: follicle-stimulating hormone; IGF-1: insulin-like growth factor-1; IGFBP-1: insulin-like growth factor binding protein-1; within-group comparison between baseline and 8 weeks of intervention (pretest vs posttest); between-group comparison at baseline (pretest metformin-placebo group vs pretest metformin-calcium-vitamin D3 group); : between-group comparison in means of changes from baseline (posttest minus pretest) (means of changes in metformin-placebo group vs means of changes in metformin-calcium-vitamin D3 group).
