Effect of vitamin D and/or magnesium supplementation on mood, serum level of BDNF, inflammation, and SIRT1 in obese women

Evaluation the effect of vitamin D and/or magnesium on mood, serum level of BDNF, inflammation, and SIRT1 in obese women

The study will be done in Phase 3 clinical trials with a control group, in a factorial design, double-blind and randomized allocation. 80 eligible obese women will be randomly allocated into 4 groups (vitamin D, magnesium, cosupplementation, placebo). For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks.

Obese women, in Iran University of Medical Science, who meet the criteria, will be randomly allocated into 4 groups (vitamin D, magnesium, cosupplementation, placebo). Mood will be assessed using the Beck Depression Inventory at baseline and after week 8. Blood samples will be taken to quantify levels of 25(OH)D, inflammatory factors, and SIRT1 at baseline and after week 8. For blinding a person who will not be involved in protocol will create the randomization list. Tablets and placebo tablets will be placed into identical containers and will be randomly labeled. Investigators and participants will be blind to random assignments.

Inclusion criteria: BMI range of 30-40 kg/m2; Aged 18-50 years; 25(OH)D < 30 ng/ml; No renal, hepatic, and gastrointestinal disorders; Not taking vitamin D and magnesium or anti-depressant and anti-inflammatory drugs. Exclusion criteria: Unwillingness to participate in study

Intervention 1: a 50000 IU vitamin D tablet, weekly+ a magnesium tablet (each tablet containing 250 mg magnesium in form of magnesium oxide), daily; Intervention 2: a 50000 IU vitamin D, weekly+a magnesium placebo, daily; Intervention 3: a magnesium tablet, daily+ a vitamin D placebo, weekly; Control: a vitamin D placebo, weekly+ a magnesium placebo.

Serum 25(OH)D; Serum TNF-α; level of IL-6; SIRT1; Serum BDNF; mood.

For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 80 subjects, 20 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable.

For blinding, a person who will not be involved in study protocol will create the randomization list assigning participants to the vitamin D, magnesium, co-supplementation or the placebo group. Vitamin D, magnesium, and placebo tablets will be placed into identical containers which study manager will label them with participant numbers using the randomization list. All investigators, and participants will be blinded to the random assignments.

A part of the data will be shared, such as primary outcomes.

Four months after the publication of the results.

Researchers and students of university.

Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis.

Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com

Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com