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Not yet recruiting NCT06957717

Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls

No phase Interventional Iron Deficiency Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cow's milk kefir, pasteurized cow's milk.
Who it may be relevant to
Registry conditions: Iron Deficiency Anemia. Basic parameters: 15 years — 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls in Yogyakarta, Indonesia

Overview

Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Long-term supplementation of blood supplement tablets (TTD) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. Giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. Method: It's research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment

Detailed description

This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.

Interventions

  • Combination product cow's milk kefir
    group given cow's milk kefir and blood supplement tablets (TTD)
  • Combination product pasteurized cow's milk
    group given pasteurized cow's milk and blood supplement tablets (TTD)

Primary outcome measures

  • Short Chain Fatty Acid [Time frame: 2 months after intervention]
  • hemoglobin [Time frame: 2 months after intervention]
  • Ferritin [Time frame: 2 months after intervention]
Secondary outcome measures (4)
  • Nutrient intake [Time frame: 2 months after intervention]
  • Nutritional status of adolescent girls (body mass index / age) [Time frame: 2 months after intervention]
  • Menstrual cycle and duration of adolescent girls [Time frame: 2 months after intervention]
  • Diarrhea [Time frame: 2 months after intervention]

Eligibility criteria

Inclusion criteria

  • Adolescent girls aged 15-18 years
  • Have a mild and moderate degree of anemia (Hb 8-11.9 g/dl)
  • Have a normal menstrual cycle and duration

Exclusion criteria

  • Suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months
  • Taking supplements other than TTD
  • Taking antibiotics in the last 3 months
  • Suffering from lactose intolerance through interviews

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Gadjah Mada University — Yogyakarta

Identifiers

NCT: NCT06957717 · GadjahMada

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗