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IRCT20230603058376N1 IRCT 2023-10-07 Ardabil University of Medical Sciences Arginine effect on height growth of children AHGC Evaluation of the effect of arginine administration on height growth of Children in lower limit range 2023-10-11 anticipated 76 Complete https://irct.ir/trial/72507 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method and Explanation for Each: Simple randomization has been utilized. In this method, each participant is randomly allocated to either the control or intervention group. Unit of Randomization: Individual-level randomization. Stratification Layers: Gender stratification has been implemented, ensuring that for every male child selected, a female child is included, and vice versa. Randomization Tool: Similar packets indicating Group A (control) or Group B (intervention). Procedure for Creating a Random Sequence: The sample size has been determined using the G-POWER software. Once participants are selected, a random sequence for entry into groups is established. Explanation on Allocation Concealment: Participants are assigned to various groups using indistinguishable packets, unaware of their contents. Consequently, participants remain blinded to their group assignments, Blinding description: To keep participants unaware of which group they belong to, similar packets will be prepared. Participants will randomly pick one of these packets, which will indicate whether they are in Group A (control) or Group B (intervention), but they will not be told the type of intervention being applied in their group. This ensures a single-blind study design. 1 Short stature. Intervention group: Vitamin D 1000 IU daily + Argenine 250mg daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is Privacy
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Ardabil university of medical sciences, Daneshgah st., Ardabil
Ardabil Iran (Islamic Republic of) 8599156189 +98 45 3353 4790 info@arums.ac.ir Ardabil University of Medical Sciences scientific Simin zare
Ardabil university of medical sciences, Daneshgah st., Ardabil
Ardabil Iran (Islamic Republic of) 8599156189 04333534790 info@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Children in pre-pubertal ages Absence of any underlying diseases Not below the lower normal height limit No indications for growth hormone prescription 5 years 15 years Both Having reached sexual maturity Presence of underlying diseases such as diabetes, hypothyroidism, or kidney diseases Height below the lower normal limit Past or current use of growth hormone Sensitivity or adverse reactions to Vitamin D or Arginine R62.52 Short stature (child) Prevention Intervention group: Vitamin D 1000 IU daily + Argenine 250mg daily Height of a child. Timepoint: 12 months with 3 month interval. Method of measurement: Height measuring device. Ardabil University of Medical Sciences Approved 2023-08-26 Ethics committee of Ardabil University of Medical Sciences Ardabil university of medcal sciences, Daneshgah st., Ardabil Ardabil Ardabil Iran (Islamic Republic of)